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Biotech Manufacturing Technician
Ref No.: 18-04664
Location: Andover, MA 01810, Massachusetts
Job Title: Biotech Manufacturing Technician
Location: One Burtt Road, Andover, MA 01810
Duration: 4 Months

Shift: Other (06:00 AM - 06:00 PM)

HM feedback: I am really looking for people with strong Cell Culture experience especially with regard to thaw to shaker flask/wave rocker inoculum.

Job Description:
  • Executes SOPs for unit operations (daily and long term).
  • Seed Lab operations, CIP, SIP, Bioreactor Harvest and Refeed operations as well as sampling.
  • Support during audits and with audit observation closure.
  • Responsible for keeping training current.
  • Maintains a safe working environment
  • Thorough understanding of cGMP requirements and safety practices.
  • Supports implementation of new technology for process execution and/or analysis.
  • Interacts across the asset to achieve production schedule.
  • Reviews documentation daily as well as perform data entry – Monitor, identify and communicate process and compliance trends real time.
  • Archives documentation according to established procedures.
  • Required to modify and/or create job-related documentation including MBRs, SOPs, MFRs, work requests and others.
  • Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
  • Provides Employs Automated systems, enterprise systems, and available technology to execute work.
  • Engages in and supports a culture of innovation and sustainable improvement through ownership of improvement for work processes, equipment and environment.

Additional Skills:
  • Ability to troubleshoot issues that arise on the manufacturing floor.
  • The incumbent is required to attain detail knowledge of the operational equipment
  • Familiarity with operation of seed lab, bioreactor harvest and refeeds and sampling with varying mixes of automation and paper SOPs

What is the minimum education experience required?:
  • High School diploma required. Associate Degree in Biotechnology or a science discipline is preferred.
  • 3+ years manufacturing experience in a GMP or other regulated environment is required.
  • Familiarity and experience with purification processes is desired.
  • 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.
  • 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.
  • Effective verbal and written communication skills