Cryogenic Process Specialist
$69,701–$84,469 year
On-siteDevens, Massachusetts, United States
Job Summary
Execute freeze-thaw processing and packaging-shipping of bulk drug substances and cold chain samples at the Devens site Cryogenic facility in accordance with cGMPs and defined process parameters. Lead and train team members while ensuring less experienced personnel comply with Standard Operating Procedures and work instructions. Review batch records for each manufacturing lot with Quality representatives, resolve issues, and independently support routine process investigations. Maintain audit readiness through strict housekeeping and safety adherence, while championing work safety initiatives and driving continual improvements to work processes and equipment. Master process automation systems including Delta V, OSI/Pi Historian, and MES Syncade to support operations.
Required Qualifications
- Associate's degree
- Bachelor's degree
- 4+ years of experience
- Knowledge of science
- Minimum of 4+ years operations experience in a facility subject to Good Manufacturing Practices (GMP) regulations
- Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP)
- Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
- Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications
- Previous work experience where attention to detail and personal accountability were critical to success
- Good interpersonal skills
- Attentive and approachable
- Maintains a professional and productive relationship with area management and co-workers
- Site-essential roles require 100% of shifts onsite at your assigned facility
Desired Qualifications
- Bachelor's degree preferred with 4+ years of experience
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline
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