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4 jobs found in verona, wisconsin

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    • madison, wisconsin
    • permanent
    • $210,000 - $230,000 per year
    job summary: Job Description: JOB OBJECTIVE: The Director, Quality Assurance is responsible for the strategic development and execution of quality assurance program including all quality-related decisions. This position reports to the Executive Director for the execution and administration of all GXP Quality Systems and is directly accountable for cGMP, GLP, GCP and GVP compliance in accordance with ICH, US, EU, and other relevant regulations. This position is expected to lead a team and collaborate across the organization on all quality matters and develop strong relationships with external consultants and contractors as necessary to support QA activities and responsibilities. The role requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP) and relevant regulations across multiple jurisdictions. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing impact within its field of research.   location: Madison, Wisconsin job type: Permanent salary: $210,000 - 230,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: CORE DUTIES: 1. Ensures that the Quality Management System meets standards expected by US and global regulatory authorities for research, development, and ultimately commercial activities. 2. Ensures quality metrics comply with best industry standards and practices. 3. Maintains effective quality governance and continually improves governance to meet organizational and compliance needs. 4. Accountable for overall quality and compliance oversight to include manufacturing, supply chain, nonclinical, and clinical functions. 5. Establishes strong working relationships with external product manufacturers and assures alignment of Quality Management Systems and requirements with these CMOs. Ensures that products manufactured at CMOs meet organizational quality standards and government regulations. 6. In collaboration with Clinical team, provides appropriate quality oversight of CROs. 7. Establishes, maintains, and leads oversight of internal Quality Management Systems. Continually evaluates and improves quality-related initiatives, priorities, and timelines. 8. Ensures that appropriate quality criteria are built into the selection/implementation of, and upgrades to, electronic systems used to support any GXP related activities. 9. Provides leadership and mentorship to the Quality team. Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met. 10. Keeps abreast of industry developments, forthcoming regulations, guidance, best practices, etc. 11. Interprets and applies quality requirements and provides guidance and training to ensure that Usona and its GxP vendors maintain an ongoing state of compliance. 12. Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Usona's Leadership Team. 13. Serves as an escalation point for organizational compliance and quality issues. 14. Serves as a primary contact in any audit by a regulatory authority and leads all audit communications with audit personnel from a regulatory agency. Responsible for supplier/vendor qualification audit and inspection management. 15. Conducts all duties in compliance with country-specific regulations, applicable SOPs, and other applicable guidelines. 16. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 17. Embracing and being open to incorporating Usona's 6 Emotional & Social Intelligence (ESI) core principles in daily work. 18. Understands and complies with ethical, legal and regulatory requirements applicable to our business.   qualifications: KEY QUALIFICATIONS: 1. Bachelor's degree, preferably in the life sciences. 2. 15+ years of relevant experience in GXP, QA leadership positions in a Biotech and/or Pharmaceutical industry. 3. Extensive knowledge and in-depth experience of implementation of Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for USA, EU and other global Health authorities. 4. Familiar with ICH Quality Guidelines and a demonstrated ability to utilize ICH Q9 / Quality Risk Management principles in everyday practice. 5. A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members. 6. Proactive in identifying opportunities with a strong solution-minded approach and flexibility to emerging challenges based on the scope and growth of the organization. 7. Strong collaborative, influencing, and interpersonal skills 8. Excellent verbal, written, and presentation skills with the ability to deal effectively across all levels of management. 9. Ability to prioritize competing activities, manage resources, and budget accordingly. PREFERRED QUALIFICATIONS: 1. Master's Degree 2. Experience/familiarity with regulations related to controlled substances 1. Proficiency with Microsoft Word, Excel, and Outlook. PHYSICAL DEMANDS: 1. Ability to use computer equipment.   skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: Job Description: JOB OBJECTIVE: The Director, Quality Assurance is responsible for the strategic development and execution of quality assurance program including all quality-related decisions. This position reports to the Executive Director for the execution and administration of all GXP Quality Systems and is directly accountable for cGMP, GLP, GCP and GVP compliance in accordance with ICH, US, EU, and other relevant regulations. This position is expected to lead a team and collaborate across the organization on all quality matters and develop strong relationships with external consultants and contractors as necessary to support QA activities and responsibilities. The role requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP) and relevant regulations across multiple jurisdictions. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing impact within its field of research.   location: Madison, Wisconsin job type: Permanent salary: $210,000 - 230,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: CORE DUTIES: 1. Ensures that the Quality Management System meets standards expected by US and global regulatory authorities for research, development, and ultimately commercial activities. 2. Ensures quality metrics comply with best industry standards and practices. 3. Maintains effective quality governance and continually improves governance to meet organizational and compliance needs. 4. Accountable for overall quality and compliance oversight to include manufacturing, supply chain, nonclinical, and clinical functions. 5. Establishes strong working relationships with external product manufacturers and assures alignment of Quality Management Systems and requirements with these CMOs. Ensures that products manufactured at CMOs meet organizational quality standards and government regulations. 6. In collaboration with Clinical team, provides appropriate quality oversight of CROs. 7. Establishes, maintains, and leads oversight of internal Quality Management Systems. Continually evaluates and improves quality-related initiatives, priorities, and timelines. 8. Ensures that appropriate quality criteria are built into the selection/implementation of, and upgrades to, electronic systems used to support any GXP related activities. 9. Provides leadership and mentorship to the Quality team. Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met. 10. Keeps abreast of industry developments, forthcoming regulations, guidance, best practices, etc. 11. Interprets and applies quality requirements and provides guidance and training to ensure that Usona and its GxP vendors maintain an ongoing state of compliance. 12. Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Usona's Leadership Team. 13. Serves as an escalation point for organizational compliance and quality issues. 14. Serves as a primary contact in any audit by a regulatory authority and leads all audit communications with audit personnel from a regulatory agency. Responsible for supplier/vendor qualification audit and inspection management. 15. Conducts all duties in compliance with country-specific regulations, applicable SOPs, and other applicable guidelines. 16. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 17. Embracing and being open to incorporating Usona's 6 Emotional & Social Intelligence (ESI) core principles in daily work. 18. Understands and complies with ethical, legal and regulatory requirements applicable to our business.   qualifications: KEY QUALIFICATIONS: 1. Bachelor's degree, preferably in the life sciences. 2. 15+ years of relevant experience in GXP, QA leadership positions in a Biotech and/or Pharmaceutical industry. 3. Extensive knowledge and in-depth experience of implementation of Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for USA, EU and other global Health authorities. 4. Familiar with ICH Quality Guidelines and a demonstrated ability to utilize ICH Q9 / Quality Risk Management principles in everyday practice. 5. A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members. 6. Proactive in identifying opportunities with a strong solution-minded approach and flexibility to emerging challenges based on the scope and growth of the organization. 7. Strong collaborative, influencing, and interpersonal skills 8. Excellent verbal, written, and presentation skills with the ability to deal effectively across all levels of management. 9. Ability to prioritize competing activities, manage resources, and budget accordingly. PREFERRED QUALIFICATIONS: 1. Master's Degree 2. Experience/familiarity with regulations related to controlled substances 1. Proficiency with Microsoft Word, Excel, and Outlook. PHYSICAL DEMANDS: 1. Ability to use computer equipment.   skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • madison, wisconsin
    • permanent
    • $110,000 - $120,000 per year
    job summary: JOB OBJECTIVE: The Manager, Quality Assurance - API is responsible for providing the direction and leadership for quality assurance processes for product quality and GMP compliance of contract manufactured Active Pharmaceutical Ingredient (API) products.   location: Madison, Wisconsin job type: Permanent salary: $110,000 - 120,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: CORE DUTIES: 1. Manage QA staff involved in key processes such as CAPA, Non conformances, Change Control, Audit, Training, and Document Control & and Records related to the manufacture of API products. 2. Design, develop, and manage key quality system processes to ensure compliance with the requirements for API products. 3. Work with QA leadership to improve quality system processes and overall quality and regulatory activities. 4. Participate in both internal and external audits; play an active role in maintaining an inspection ready state. 5. Represent Promega in discussions/interactions with regulatory bodies, partners, vendors, or customers. 6. Actively coach, mentor and develop team members and leaders within the department. 7. Lead and support cross-departmental, corporate, and team projects and initiatives. 8. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 9. Embracing and being open to incorporating 6 Emotional & Social Intelligence (ESI) core principles in daily work. 10. Understands and complies with ethical, legal and regulatory requirements applicable to our business. KEY QUALIFICATIONS: 1. University degree (B.S. or M.S.) in a biological or chemical science or other relevant field. 2. Minimum of 10 years related experience in quality control, quality assurance, product support, or manufacturing. 3. Working knowledge of quality standards governing API products including 21 CFR 210 & 211 and ICH Q7. 4. Ability to understand basic statistical concepts and analytical data. 5. Ability to communicate (in written and oral forms) in a concise, clear, and accurate manner. 6. Proven ability to work constructively with a broad range of people, backgrounds, and functions. 7. Ability to perform analysis of complex problems or data requiring in-depth evaluation of various factors. 8. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. 9. Proficient with electronic tools including Microsoft Office applications and eQMS programs.   qualifications: PREFERRED QUALIFICATIONS: 1. Technical knowledge or experience in scientific areas specifically applicable to small molecule drug manufacturing. 2. Previous experience managing FDA inspections. PHYSICAL DEMANDS: 1. Ability to remain stationary and use a computer for extended periods of time.   skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: JOB OBJECTIVE: The Manager, Quality Assurance - API is responsible for providing the direction and leadership for quality assurance processes for product quality and GMP compliance of contract manufactured Active Pharmaceutical Ingredient (API) products.   location: Madison, Wisconsin job type: Permanent salary: $110,000 - 120,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: CORE DUTIES: 1. Manage QA staff involved in key processes such as CAPA, Non conformances, Change Control, Audit, Training, and Document Control & and Records related to the manufacture of API products. 2. Design, develop, and manage key quality system processes to ensure compliance with the requirements for API products. 3. Work with QA leadership to improve quality system processes and overall quality and regulatory activities. 4. Participate in both internal and external audits; play an active role in maintaining an inspection ready state. 5. Represent Promega in discussions/interactions with regulatory bodies, partners, vendors, or customers. 6. Actively coach, mentor and develop team members and leaders within the department. 7. Lead and support cross-departmental, corporate, and team projects and initiatives. 8. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 9. Embracing and being open to incorporating 6 Emotional & Social Intelligence (ESI) core principles in daily work. 10. Understands and complies with ethical, legal and regulatory requirements applicable to our business. KEY QUALIFICATIONS: 1. University degree (B.S. or M.S.) in a biological or chemical science or other relevant field. 2. Minimum of 10 years related experience in quality control, quality assurance, product support, or manufacturing. 3. Working knowledge of quality standards governing API products including 21 CFR 210 & 211 and ICH Q7. 4. Ability to understand basic statistical concepts and analytical data. 5. Ability to communicate (in written and oral forms) in a concise, clear, and accurate manner. 6. Proven ability to work constructively with a broad range of people, backgrounds, and functions. 7. Ability to perform analysis of complex problems or data requiring in-depth evaluation of various factors. 8. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. 9. Proficient with electronic tools including Microsoft Office applications and eQMS programs.   qualifications: PREFERRED QUALIFICATIONS: 1. Technical knowledge or experience in scientific areas specifically applicable to small molecule drug manufacturing. 2. Previous experience managing FDA inspections. PHYSICAL DEMANDS: 1. Ability to remain stationary and use a computer for extended periods of time.   skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • verona, wisconsin
    • permanent
    • $42,000 - $52,000 per year
    job summary: Randstad is the #1 HR Services Company in the world and we are sourcing for a QC Chemist position in the Madison, WI area. The primary purpose of the QC Analytical Chemist is to provide support to the Production and Formulations Departments by analyzing pharmaceutical and/or cleaning samples. Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs, client procedures, and miscellaneous protocols. The QC Analytical Chemist is expected to understand basic internal procedures, and conduct analyses with some supervision after training is complete. This is a direct hire position and can start immediately.   location: Verona, Wisconsin job type: Permanent salary: $42,000 - 52,000 per year work hours: 8 to 4 education: Bachelors   responsibilities: Responsibilities: Ensures adherence to CPI Standard Operating Procedures, analytical methods, protocols, company standards, and applicable regulations.Analyzes pharmaceutical or cleaning samplesAbility to weigh samples, pipette, and prepare laboratory solutionsPerforms or assists with basic calibrationsMaintains a cGMP laboratory notebook, data, forms, and/or logbook.Assists in maintaining a clean, organized QC laboratory.Lifts/carries objects weighing up to 55 lbs.Follows all CPI cGMP practices, policies, and procedures.Follows all CPI safety practices, policies, and procedures.Other duties as assigned.  qualifications: Requirements: Bachelor's degree in Chemistry or related field.Experience with the use and troubleshooting of laboratory equipment desirable.Possesses good time management skills to complete assignments/projects in a timely manner with minimal supervision.Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients. Working Conditions The QC Analytical Chemist works in a cGMP laboratory and production environment. Working in these environments will require working near skin irritants, electrical equipment, sharp instruments, toxic materials, and hazardous chemicals including controlled substances. Safety procedures must be followed to limit exposure.   skills: Quality control, SOP, Quality Assurance, Analytical Chemistry, Biology, Chemistry, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: Randstad is the #1 HR Services Company in the world and we are sourcing for a QC Chemist position in the Madison, WI area. The primary purpose of the QC Analytical Chemist is to provide support to the Production and Formulations Departments by analyzing pharmaceutical and/or cleaning samples. Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs, client procedures, and miscellaneous protocols. The QC Analytical Chemist is expected to understand basic internal procedures, and conduct analyses with some supervision after training is complete. This is a direct hire position and can start immediately.   location: Verona, Wisconsin job type: Permanent salary: $42,000 - 52,000 per year work hours: 8 to 4 education: Bachelors   responsibilities: Responsibilities: Ensures adherence to CPI Standard Operating Procedures, analytical methods, protocols, company standards, and applicable regulations.Analyzes pharmaceutical or cleaning samplesAbility to weigh samples, pipette, and prepare laboratory solutionsPerforms or assists with basic calibrationsMaintains a cGMP laboratory notebook, data, forms, and/or logbook.Assists in maintaining a clean, organized QC laboratory.Lifts/carries objects weighing up to 55 lbs.Follows all CPI cGMP practices, policies, and procedures.Follows all CPI safety practices, policies, and procedures.Other duties as assigned.  qualifications: Requirements: Bachelor's degree in Chemistry or related field.Experience with the use and troubleshooting of laboratory equipment desirable.Possesses good time management skills to complete assignments/projects in a timely manner with minimal supervision.Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients. Working Conditions The QC Analytical Chemist works in a cGMP laboratory and production environment. Working in these environments will require working near skin irritants, electrical equipment, sharp instruments, toxic materials, and hazardous chemicals including controlled substances. Safety procedures must be followed to limit exposure.   skills: Quality control, SOP, Quality Assurance, Analytical Chemistry, Biology, Chemistry, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • madison, wisconsin
    • permanent
    • $62,000 - $90,000 per year
    job summary: About Our Client: We are the Operations Validation Team. We are made up of different specialists who play multiple roles: statistical data scientists, process validation engineers, analytical method validation engineers. We provide our expertise in all things Validation. We lend our expertise to validating products, processes, analytical methods, and qualifying equipment that supports our Class 1 Medical Devices. Our diverse internal clientele includes all areas of Bulk Manufacturing, Customs Manufacturing and R&D business units. YOUR ROLE: Lead and execute validation and qualification activities of equipment and processes while working in a team environment. Independently draft, review, execute validation and qualification protocols per industry practices and internal guidelines. The position requires working knowledge and experience in the qualification of bulk manufacturing process equipment and facilities utilities. Experience with equipment and process validation is highly desirable. JOB OBJECTIVE: Perform the Process Validation activities for all manufacturing equipment, manufacturing processes, and critical utilities.   location: Madison, Wisconsin job type: Permanent salary: $62,000 - 90,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: CORE DUTIES: 1. Work with the Engineering lead and Validation Team to produce resource estimates and schedules for the process validation tasks on new projects. Manage schedule activities for successful completion of validation tasks. 2. Assist in creating Validation Master Plans for process validation projects. 3. Responsible for preparation and execution of process validation test procedures and acceptance criteria for process equipment and critical utilities validation protocols. 4. Work directly with equipment vendors to assist them in development of process design and validation documentation, and in facilitating review/approvals within Promega. 5. Assist Validation Lead in turnover of validated systems to process owners. 6. Project Management - Assist Project Managers in developing the validation planning portions of project plans, and in scoping the resources required for successful implementation of validation. 7. Serve as process validation expert resource for in the IVD (21 CFR Part 820) regulated industry. 8. Serve as technical resource for specification of equipment for automation projects. 9. Proactively maintain working knowledge of current industry trends and developments in the process validation field. 10. Provide support to Management for special projects or duties. 11. Present updates and departmental information at various company meetings. 12. Attend relevant validation meetings and technical seminars. 13. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 14. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work. 15. Understands and complies with ethical, legal and regulatory requirements applicable to our business. KEY QUALIFICATIONS: 1. BS in Mechanical Engineering, or related Engineering discipline. 2. Two or more years of process validation development and execution experience in a manufacturing environment in the biotech, pharmaceutical, or IVD industry. 3. Strong interpersonal and communication skills.   qualifications: PREFERRED QUALIFICATIONS: 1. Advanced Degree (M.S. or PhD) in Engineering related discipline. 2. Certification as a Validation Engineer. 3. Two or more years of process validation development and execution experience in a manufacturing environment in the Medical Device industry. 4. Experience implementing automated packaging equipment projects. PHYSICAL DEMANDS: 1. Ability to observe and inspect equipment and operations for proper operation and compliance to safety and housekeeping standards. 2. Ability to work in a production environment around automated equipment. 3. Ability to work in an office environment utilizing a computer workstation. 4. Ability to work in a lab environment with chemical, biological and packaging materials. 5. Ability to travel by car or airplane, for one or several days, to suppliers, equipment vendors, trade shows, etc.   skills: Process Engineering Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: About Our Client: We are the Operations Validation Team. We are made up of different specialists who play multiple roles: statistical data scientists, process validation engineers, analytical method validation engineers. We provide our expertise in all things Validation. We lend our expertise to validating products, processes, analytical methods, and qualifying equipment that supports our Class 1 Medical Devices. Our diverse internal clientele includes all areas of Bulk Manufacturing, Customs Manufacturing and R&D business units. YOUR ROLE: Lead and execute validation and qualification activities of equipment and processes while working in a team environment. Independently draft, review, execute validation and qualification protocols per industry practices and internal guidelines. The position requires working knowledge and experience in the qualification of bulk manufacturing process equipment and facilities utilities. Experience with equipment and process validation is highly desirable. JOB OBJECTIVE: Perform the Process Validation activities for all manufacturing equipment, manufacturing processes, and critical utilities.   location: Madison, Wisconsin job type: Permanent salary: $62,000 - 90,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: CORE DUTIES: 1. Work with the Engineering lead and Validation Team to produce resource estimates and schedules for the process validation tasks on new projects. Manage schedule activities for successful completion of validation tasks. 2. Assist in creating Validation Master Plans for process validation projects. 3. Responsible for preparation and execution of process validation test procedures and acceptance criteria for process equipment and critical utilities validation protocols. 4. Work directly with equipment vendors to assist them in development of process design and validation documentation, and in facilitating review/approvals within Promega. 5. Assist Validation Lead in turnover of validated systems to process owners. 6. Project Management - Assist Project Managers in developing the validation planning portions of project plans, and in scoping the resources required for successful implementation of validation. 7. Serve as process validation expert resource for in the IVD (21 CFR Part 820) regulated industry. 8. Serve as technical resource for specification of equipment for automation projects. 9. Proactively maintain working knowledge of current industry trends and developments in the process validation field. 10. Provide support to Management for special projects or duties. 11. Present updates and departmental information at various company meetings. 12. Attend relevant validation meetings and technical seminars. 13. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 14. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work. 15. Understands and complies with ethical, legal and regulatory requirements applicable to our business. KEY QUALIFICATIONS: 1. BS in Mechanical Engineering, or related Engineering discipline. 2. Two or more years of process validation development and execution experience in a manufacturing environment in the biotech, pharmaceutical, or IVD industry. 3. Strong interpersonal and communication skills.   qualifications: PREFERRED QUALIFICATIONS: 1. Advanced Degree (M.S. or PhD) in Engineering related discipline. 2. Certification as a Validation Engineer. 3. Two or more years of process validation development and execution experience in a manufacturing environment in the Medical Device industry. 4. Experience implementing automated packaging equipment projects. PHYSICAL DEMANDS: 1. Ability to observe and inspect equipment and operations for proper operation and compliance to safety and housekeeping standards. 2. Ability to work in a production environment around automated equipment. 3. Ability to work in an office environment utilizing a computer workstation. 4. Ability to work in a lab environment with chemical, biological and packaging materials. 5. Ability to travel by car or airplane, for one or several days, to suppliers, equipment vendors, trade shows, etc.   skills: Process Engineering Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

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