MasterCompliance LLC
Sr. Manufacturing process Engineer - Pharma-biotech only
MasterCompliance LLC, Durham, North Carolina, United States, 27703
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: Bachelors or advanced degree in Biology, Biochemistry, Chemical Engineering, or a related field. 710 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 Sign in to set job alerts for Manufacturing Process Engineer roles. #J-18808-Ljbffr
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: Bachelors or advanced degree in Biology, Biochemistry, Chemical Engineering, or a related field. 710 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 Sign in to set job alerts for Manufacturing Process Engineer roles. #J-18808-Ljbffr