Manufacturing Process Technician (JP4491)​

Location: Woburn, MA
Date Posted: 07-12-2018
Job Title: Manufacturing Process Technician (JP4491)
Location: Woburn, MA.
Employment Type:  Contract
Business Unit:   AWM DP Mfg.
Duration:  9+ months (likely extensions)
 
3Key Consulting Inc. is looking for an Manufacturing Process Technician  with 1 – 2 years’ experience in a laboratory, with knowledge or microbiology, aseptic technique, and GMP for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
Under general supervision, candidate will perform routine procedures in support of the Environmental and Clean Utility Microbiological Monitoring programs. Specific responsibilities include but are not limited to the following:
  • Environmental monitoring and sampling (Laser Particle Counter/ Slit-to-Agar Sampler/ Contact Plates) of the Amgen Grade 7 and 8 manufacturing controlled and classified environments during “At Rest” (Static) conditions as well as the Cell Culture Incubators.
  • Water and Pure Steam sampling.
  • Compressed Air and Gas sampling (viable and non-viable) and testing (water vapor).
  • Coordination of samples in SM-LIMS
In addition, this position will provide support to the manufacturing process. Specific responsibilities may include but are not limited to the following:
  • Request and/or generation of In-Process and SM-LIMS labels.
  • Critical Monitoring System (CMS) Alarm Response for Manufacturing Equipment.
  • Routine cleaning of manufacturing equipment.
  • Visual Inspection of Filled Drug Product Vials.
  • Providing and communicating results, maintaining/operating specialized equipment, and initiating and/or implementing changes in controlled documents.
  • Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, building monitoring systems and laboratory log books.
 
Top Must-Have
  • Microbiology knowledge.
  • Aseptic technique knowledge.
  • GMP knowledge
 
Basic Qualifications:
Laboratory experience.
 
Day to Day Responsibilities:
Routine environmental monitoring and critical utility sampling within the manufacturing facility.
 
Why This Position Is Open:
Backfill.
 
Employee Value Proposition:
This is a good opportunity for an entry level type associate to get their foot in the door at one of the best bio-pharma companies. The role has potential for cross training to develop skills in other manufacturing processes.
 
Red Flags:
  • Candidate does not have GMP manufacturing experience or previous industry experience.
  • Candidate has large gaps in career experience
 
Interview process:
Phone interview followed by in-person
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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