Process Development Technician II

Company: Apex Life Sciences ( Learn More )

General Information
US-MA-Andover
N/A
High School
Contractor
Not Specified
Not Specified
False
False
Job Description

Apex Life Sciences is seeking a Biotech Manufacturing Technician in the Andover, MA area!

Responsibilities:

  • Executes SOPs for unit operations (daily and long term). Includes CIP, SIP, and cleaning and sanitization of the facility 
  • Operates of buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids with varying mixes of automation and paper SOPs involved. 
  • 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 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.
  • 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.
  • Strives for Right first time execution through flawless execution and ownership of the process.
  • Skills:

  • High School diploma required. Manufacturing experience in a GMP or other regulated environment is required.
  • 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.
  • 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
  • Job Requirements