Process Engineer I
6 days ago
The Manufacturing Sciences & Technology (MSAT) group plays a critical role in successful manufacturing of clinical and commercial products. As a Process Engineer I, you will assist the MSAT team in the transfer of technologies, process validation and cGMP manufacturing of Genezen's 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, etc.
- Assist manufacturing technical support, including process trouble-shooting, root cause analysis and investigation on process and/or quality discrepancies and deviations during GMP productions, change controls and CAPAs
- Cross functionally collaborate with Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation and Supply Chain as needed
- Support planning and execution of process/product life cycle management, including continuous process improvements to improve process robustness/capacity/productivity, and to increase level of safety and/or compliance
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
- Bachelor's Degree in Engineering or other related scientific discipline
- Master's Degree in Engineering or other related scientific discipline
- BS (0-3) or MS (0-1) with relevant experience or degree in gene therapy or other biotechnology field
- 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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Process Engineer I
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