Process Engineer - Upstream/Downstream 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).
Responsibilities:- 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 Client network
- Strong communication and technical writing skills are required.
Qualifications:
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.
Additional Information: All your information will be kept confidential according to EEO guidelines.
