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location: Andover, Massachusetts
job type: Contract
salary: $21.56 - 25.36 per hour
work hours: 7 to 3
education: High School
responsibilities: Job Responsibilities
- The Senior Process Technician drives the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The Senior Process Technician will work on interdisciplinary self-directed teams, to define and implement process improvements, participate in process troubleshooting.
- Executes the implementation of SOPs for unit operations including but not limited to, CIPs, SIPs, Sanitization, etc.
- Implements the execution and issue resolution associated with process equipment commissioning, qualification and validation.
- Drives troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
- Drives for Right first time execution, the timely review of daily documentation and executes data entry; Monitor, Identify and/or Communicate process and compliance trends in real time.
- Supports the assigned audit lead for walkthroughs and observation improvements.
- View Role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.
- Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
- Responsible for remaining current and reviews curriculum for training programs in support of manufacturing processes.
- Implements Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
- Collaborates with cross-functional manufacturing assets in support of manufacturing campaigns.
- Collaborates in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
- Proficient in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
qualifications: Education & Qualifications
- High School Diploma and 3 years of relevant experience required.
- Experience in a GMP manufacturing environment .
- The incumbent is required to attain detail knowledge of the operational equipment.
- The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.
- The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.
- Familiarity and experience mammalian cell culture.
- The ability to execute against SOP's and document entries in a cGMP compliant manner.
- Ability to interpret and prioritize workflow to maintain the production schedule.
- Effective verbal and written communication skills.
- Requires the moving of heavy equipment and the ability to lift ~50 pounds. The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals.
skills: SOP, Cell Cultures, GMP (Good Manufacturing Practice), Manufacturing Operations
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.