MS&T Process Engineer

The Fountain Group is currently seeking a ­­­­­­­­MS&T Process Engineer for a prominent pharmaceutical client of ours. This position is located in ­­Princeton, NJ. Details for the position are as follows:

Pay Range: $50 - 60/hr depending on experience
W2 Contract: 6-7 months (possible temp to hire)
100% onsite (non-local candidates must be able to relocate at own expense)

Job Description:

• Provide technical leadership and support to Princeton, NJ cGMP manufacturing facility that ensures cell therapy processes are robust, scalable and cGMP compliant.
• Drive seamless technology transfer, reliable cGMP manufacturing, and continuous improvement to enable the site to deliver safe, high-quality therapies to patients with speed, precision, and operational excellence. Serve as Process Subject Matter Expert (SME) and process owner for technology transfer and new product introduction.
• Perform technology transfer facility, process, workflow, and equipment fit assessment, process gap analysis, and process risk assessment when on-boarding new programs.
• Author, review, and approve internal cGMP technical documents (e.g., Batch records, SOPs, Sample Plans, and protocols).
• Author and approve protocols and reports per internal and external regulatory expectations.
• Provide on-the-floor technical support to manufacturing including process execution and troubleshooting, Quality Event triage, root cause analysis, and CAPA implementation.
• Compile, trend, analyze, and summarize cGMP manufacturing data using processing trending and statistical analysis tools.
• Identify and implement process improvements and operational efficiencies using data driven approaches.
• Represent MS&T as the technical Subject-Matter-Expert on internal and client-facing project teams.
• Assist Manufacturing and Supply Chain with new equipment introduction and new material assessment and onboarding.
• Support equipment and systems validation activities, including review of equipment qualification documents, drafting User Requirement Specifications, and providing technical input for impact assessments. Lead lifecycle management and process validation activities, including authoring and approving PV strategies, supporting PPQs, evaluating process changes, and maintaining regulatory alignment during program transition from clinical to commercial phases.
• Work with Process Development to identify, test, and implement new technologies and capabilities for the cGMP manufacturing facility.

Qualifications:

• BSc and/or Advanced degree in Science or Engineering
• Minimum 5 years of industry experience
• Minimum 3 years relevant experience in cGMP biologic/cell therapy manufacturing or related industry
• Scientific understanding in bioprocessing principles. Familiarity with cell therapy processes, cleanroom facilities and equipment is strongly preferred.
• Demonstrated understanding of Title 21 CFR Part 11 and 21 CFR Parts 210 and 211 cGMP regulations, including their application to cGMP facilities, personnel training, equipment, materials, records, documents, manufacturing processes, packaging, and labeling.
• Experience in equipment and process qualification and validation strategies and methodologies.

Who We Are:

The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.

Browse our website below for additional information on our company.

The Fountain Group

3407 West Martin Luther King Blvd., Suite 150, Tampa, FL 33607

“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”

If you are interested in hearing more about this position or other opportunities I may have please respond to this posting with your updated resume or contact me at olivia.larkin@thefountaingroup.com.

Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.

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