Manufacturing Process Engineer
Manufacturing Process Engineer
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Job Description
Job Description:
We are seeking a Manufacturing Process Engineer to join the Manufacturing Science and Technology (MS&T) team supporting latestage 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 crossfunctional environment.
Responsibilities:
- Implement and support latestage 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 latestage 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 singleuse 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 crossfunctional investigations leading or supporting root cause analysis and proposing datadriven corrective actions.
- Ensure alignment with cGMP FDA ICH and internal quality standards throughout all activities.
- Engage proactively with crossfunctional stakeholders to ensure manufacturing processes meet regulatory and operational expectations.
Requirements:
- Bachelors or advanced degree in Biology Biochemistry Chemical Engineering or a related field.
- 8 10 years of handson 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 latestage tech transfer and manufacturing process implementation.
- Familiarity with risk management tools and E&L assessments.
- Experience with singleuse 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.
Employment Type
Full Time
