Project Engineer Intern assisting with various construction project tasks in Boston, MA. Engaging in scheduling, estimating, and quality control within the PECD program.
About the role
- Process Engineer at Aura Biosciences focusing on tech transfer and upstream manufacturing for oncology therapies. Collaborating across teams to ensure successful engineering and GMP runs.
Responsibilities
- Lead and support tech transfer of cell culture and harvest processes to and within external partners, including gap assessments and readiness evaluations.
- Serve as upstream technical SME during engineering runs, GMP campaigns, and PPQ execution.
- Act as Person-in-Plant (PIP) at CDMOs providing front-line technical oversight.
- Drive resolution of manufacturing deviations, investigations, and change controls related to upstream unit operations.
- Collaborate cross-functionally with PD, AD, QA, QC, Supply Chain and Regulatory teams to ensure alignment through tech transfer and lifecycle management.
- Support development and execution of control strategies, risk assessments (FMEA), and continued process verification.
- Review and approve batch records, SOPs, and technical documentation.
- Analyze process performance data using statistical tools to monitor robustness and identify improvement opportunities.
- Support authoring and review of CMC sections related to upstream manufacturing for regulatory filings.
- Contribute to process scalability strategies and manufacturing readiness for commercial launch.
Requirements
- B.S. or M.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related Life Sciences discipline
- 4+ years (Process Engineer) or 6–8+ years (Senior Process Engineer) of relevant industry experience in biologics upstream manufacturing
- Direct experience with cell culture, bioreactors, viral production systems, transient transfections or biologics fermentation platforms
- Demonstrated experience working with external CDMO s and supporting GMP manufacturing
- Strong knowledge of cGMP regulations and global regulatory expectations
- Experience supporting engineering runs and/or PPQ campaigns preferred
- Ability to interpret and trend process data to support root cause investigations
- Strong written and verbal communication skills
- Ability to travel ~20–30% as required for manufacturing oversight.
Benefits
- Health insurance with FULL premium coverage
- 401K with company match
- Employee Stock Purchase Program (ESPP)
- Competitive paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
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