The Client's 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 Client network.
- B.S. /M.S. or Ph.D. in Chemical Engineer, Biochemical Engineer, Biomedical Engineer, Biochemistry or related field (Advanced degree is preferred).
- 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).
- Strong communication and technical writing skills are required.
- 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.
- Experience performing manufacturing investigations for biologics manufacturing.
- Experience providing start-up support for new biologics manufacturing processes (Person-In-Plant).
- Experience with statistical methodologies (DOE, SPC, etc.), cGMP regulations, and regulatory requirements is expected.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Karen: firstname.lastname@example.orgHelp
ALPHA'S REQUIREMENT #18-00772
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE