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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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Axelon Services, Corp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity, national origin, disability, or protected veteran status.