Process Engineer III, Manufacturing Sciences & Technology

Process Engineer III, Manufacturing Sciences & Technology

Lexington, MA

The MSAT group plays a critical role in successful manufacturing of clinical and commercial products. The role assists in the transfer of technologies, process validation, and cGMP manufacturing of products. This individual contributes as a core member of cross‑functional teams and interacts extensively with Process Development, Manufacturing, Engineering, Quality, and Regulatory Affairs.

• Supports downstream processing unit operations for process implementation, data collection, data analysis, and real‑time troubleshooting (chromatography, filtration, TFF, buffer generation, drug product filling).
• Assists technology transfer to GMP manufacturing by reviewing process description documents, technology transfer reports, master batch records, and providing on‑floor support for transfer operations.
• Provides manufacturing technical support, including process trouble‑shooting, root‑cause analysis, and investigation of process/quality discrepancies and deviations during GMP productions, change controls, and CAPAs.
• Supports the plan and execution of process/product life‑cycle management, including continuous process improvement to improve robustness, capacity, productivity, and safety/compliance.
• Performs statistical analysis of process data (generation and trending control charts, linear regression, multivariate analysis).

• Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner.
• Experience with statistical analysis of process data.
• Criminal background check required.
• Other duties as assigned.

• Strong communication skills at individual, team, and organizational levels; fluent in English.
• Experience in process development/analytical development/MSAT or GMP manufacturing preferable in viral vaccines or gene therapy.
• Experience with technology transfer and GMP manufacturing technical support.
• Familiarity with EMA/FDA regulations, ICH guidelines, GMP and quality systems.
• Strong communication skills, including writing and oral presentations.
• Proactive attitude, flexibility, professionalism, independence, and teamwork.
• Experienced project management skills.

• 3–6 years (BS) or 1–4 years (MS) of relevant experience in gene therapy or biotechnology industry.

BS/MS or degree in Engineering or related scientific discipline preferred.

• Regularly sit for long periods of time.
• Frequently stand, sit, use hands, reach, and occasionally walk, climb, balance, stoop, kneel, crouch, or crawl.
• Frequently lift up to 10 pounds, occasionally lift up to 25 pounds.
• Frequently use close vision and communicate by talking, hearing, telephone, and e‑mail.

The annual salary range for this position is $105,000–$130,000.

• Paid vacation days, amount based on tenure.
• 401(k) plan with company match up to 6% of salary, vested immediately.
• Choice of several healthcare plans.
• FSA and HSA programs.
• Employer‑paid basic term life/personal accident insurance.
• Voluntary disability and universal life/personal accident insurance.

• Nothing in the job description restricts management’s right to assign or re‑assign duties and responsibilities.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen will not sponsor visas.