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Process Engineer
Ref No.: 18-10949
Location: Devens, Massachusetts
Job Description: Process Engineer
The company Devens, MA MS&T organization is seeking to fill a Process Engineer position for an 8+ month contract. The successful candidate will provide meaningful contributions toward commercial manufacturing support, process monitoring, technology transfer and process validation activities. The successful candidate will have a demonstrated background in bioprocessing (upstream and/or downstream), experience troubleshooting manufacturing processes and strong technical documentation skills (memos, protocols, reports).
- Work independently to provide commercial manufacturing technical support, process monitoring, technology transfer and process validation activities for downstream processes.
- Provide process troubleshooting during scale-up and routine manufacturing. Provide process subject matter expertise and ownership of assigned deliverables.
- The successful candidate will work effectively in highly cross-functional project teams, matrix management environments, as well as independent working environments to support the site.
- Perform data analysis and monitoring for process performance and product quality outputs.
- The position will interface with Manufacturing, Quality, Engineering, and internal MS&T departments at multiple sites throughout the company network
- Strong communication and technical writing skills are required.
- B.S./M.S. or Ph.D. in Chemical Engineer, Biochemical Engineer, Biomedical Engineer, Biochemistry or related field (Advanced degree is preferred)
- Required: Prior experience (Ph.D: 0 – 2 years; BS/MS: 2 – 6 years) in process development, process validation or manufacturing support in bioprocessing (upstream and/or downstream)
- Preferred: Prior experience scaling up biopharma manufacturing processes (upstream/downstream), facility fit assessments, process scale-up from bench/pilot to production, process troubleshooting and optimization, and process validation. Hands-on experience working with chromatography, ultrafiltration and depth filtration process acquired through lab, pilot or production scale experience.
- Preferred: Experience performing manufacturing investigations for biologics manufacturing.
- Preferred: Experience providing start-up support for new biologics manufacturing processes (Person-In-Plant)
- Preferred: Experience with statistical methodologies (DOE, SPC, etc), cGMP regulations, and regulatory requirements is expected.

Keywords: Manufacturing Technical Support (MTS), Manufacturing Sciences & Technology (MS&T/MSAT), process validation, PPQ, technology transfer, facility fit, scale-up, process development, bioprocessing
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