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Process Development Technician II

Andover, MARandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/300389
 

Chat with me now! - https://flashrecruit.com/jobs/298400
 

Process Development Technician II

True Job Title: Biotech Manufacturing Technician 

 

Job Summary

  • This person will be doing cell culture and media preparation primarily, but either cell culture or purification experience is required (similar experience with counting and basic SOPs and GMP operations)
  • Bioreactors
  • Buffer & Media Preparation
  • SOPs & working with automated systems

Job 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.

Education & Qualifications

  • High school with GMP manufacturing experience
  • Associated Degree is highest level of education accepted
  • Must have at least 1 year of Biotech Manufacturing experience (6 months min, but this is often not enough to hit the ground running) - open to several years of experience, too
  • Looking for Cell culture OR Purification experience
  • Experience working with SOPs
  • 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.

Shift Schedule

  • 6:00 am  - 6:00 pm (11.5-hr day, 30 min for lunch)
  • 2 days on 3 days off, and it rotates - every other weekend
  • They do work Holidays 

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/298400

 

 


Chat with me now! - https://flashrecruit.com/jobs/300389