Process Engineer I

6 days ago


Lexington, Massachusetts, United States Genezen Full time
Job Summary

The Manufacturing Sciences & Technology (MSAT) group plays a critical role in the successful manufacturing of clinical and commercial products at Genezen. We are seeking a highly skilled Process Engineer I to assist the MSAT team in the transfer of technologies, process validation, and cGMP manufacturing of our gene therapy products.

Key Responsibilities
  • Assist technology transfer to GMP manufacturing facilities by reviewing master batch records and providing on-floor support for transfer operations.
  • Verify technical data in support of reports, impact assessments, memos, and other documentation.
  • Collaborate with cross-functional teams, including Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation, and Supply Chain.
  • Support planning and execution of process/product life cycle management, including continuous process improvements to enhance process robustness, capacity, productivity, safety, and compliance.
Requirements
  • Bachelor's Degree in Engineering or a related scientific discipline.
  • Master's Degree in Engineering or a related scientific discipline (desired).
  • BS (0-3) or MS (0-1) with relevant experience or degree in gene therapy or other biotechnology field.
  • Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal.
  • Ability to present to and interact with others to achieve cross-functional goals.
  • Ability to handle pressure and address multiple topics in parallel to meet timelines.
  • Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner.
Benefits
  • Paid vacation days, amount based on tenure.
  • Paid sick time.
  • 9 observed holidays + 1 floating holiday + 1 volunteer day.
  • 401(k) plan with company match up to 6% of salary, vested immediately.
  • Share Appreciation Rights.
  • Choice of several healthcare plans.
  • FSA and HSA programs.
  • Dental & vision care.
  • Employer-paid basic term life/personal accident insurance.
  • Voluntary disability, universal life/personal accident insurance.
  • Accidental Death & Dismemberment (AD&D) Insurance.

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