Sr. Manufacturing Process Engineer - Pharma-biotech only
Direct message the job poster from Master Compliance
Technical Recruiter @Grove Technical Resources
Job Title: Manufacturing Process Engineer – Cell Therapy MS&T
Location: Durham, NC (Fully Onsite, 5 Days/Week)
Hours/Week: 40
Position Summary:
We are seeking a Manufacturing Process Engineer to join the Manufacturing Science and Technology (MS&T) team, supporting late-stage manufacturing and PPQ readiness for an autologous cell therapy product. This role requires a strong background in GMP operations, process control strategy implementation, risk assessment, and manufacturing support. The engineer will serve as a subject matter expert (SME) driving technical excellence, ensuring process robustness, and supporting regulatory compliance in a cross-functional environment.
Key Responsibilities:
- Implement and support late-stage manufacturing process control strategies for cell therapy drug product.
- Analyze and monitor process performance data to ensure process consistency and readiness for PPQ.
- Collaborate with process development and manufacturing teams to support tech transfer activities and execution of late-stage PD deliverables.
- Participate in the preparation and execution of ancillary PPQ protocols (e.g., buffer stability, intermediate hold times) and summary reports.
- Contribute to risk assessments , including Extractables & Leachables (E&L), and consumables qualification.
- Support the selection and justification of single-use systems and sterile processing equipment.
- Review and interpret SOPs and execute work instructions related to manufacturing readiness and qualification efforts.
- Act as an MS&T representative in cross-functional investigations , leading or supporting root cause analysis and proposing data-driven corrective actions.
- Ensure alignment with cGMP, FDA, ICH, and internal quality standards throughout all activities.
- Engage proactively with cross-functional stakeholders to ensure manufacturing processes meet regulatory and operational expectations.
Qualifications:
- Bachelor’s or advanced degree in Biology, Biochemistry, Chemical Engineering, or a related field.
- 7–10 years of hands-on MS&T or manufacturing engineering experience in a GMP cell/gene therapy environment.
- Strong knowledge of PPQ, PV lifecycle, cGMP, ICH, and FDA guidelines .
- Proven experience supporting late-stage tech transfer and manufacturing process implementation.
- Familiarity with risk management tools and E&L assessments .
- Experience with single-use systems , sterile manufacturing , and consumables qualification is highly preferred.
- Excellent skills in interpreting and executing SOPs and contributing to protocols and technical reports .
- Effective communicator with strong collaboration skills and the ability to work independently with minimal supervision.
Seniority level
- Mid-Senior level
Employment type
- Contract
Job function
- Engineering and Health Care Provider
- Industries: Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at Master Compliance by 2x