Process Development Technician II

  • location: Andover, MA
  • type: Contract
  • salary: $22.69 - $26.70 per hour
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job description

Process Development Technician II

job summary:




As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With therapeutic areas that include Oncology, Vaccines, and Rare Diseases, our partner aims to make treatments streamlined, easily accessible, and globally produced. If you share their goal of approaching healthcare in a novel way, look no further - apply for your dream job now!



 
location: Andover, Massachusetts
job type: Contract
salary: $22.69 - 26.70 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:
  • High School Diploma and 2years 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.
PREFERRED QUALIFICATION

  • Familiarity with SAP, LWLIMS
  • Familiarity and experience with either purification processes or mammalian cell culture.
  • Support operations (such as solution preparation and/or operation of autoclave/depyrogenation ovens) is not essential but is highly desirable.
  • 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.
PHYSICAL/MENTAL REQUIREMENTS

  • 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.
  • 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.
 
skills: SOP, Laboratory Information Management Systems (LIMS), 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.

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