Associate Engineer II, Polysaccharide Manufacturing
Skills
- Experience in GMP manufacturing environments and process development
- Hands-on experience with in-process analytical techniques (colorimetric and enzymatic assays)
- Familiarity with upstream and downstream processing (fermentation, UF/DF, depth filtration, chromatography)
- Experience supporting technology transfer, scale-up, or CDMO-based manufacturing
- Ability to perform deviation investigations and root cause analysis
- Proficiency in data analysis and statistical tools (JMP preferred)
- Experience using electronic lab notebook (ELN) systems
- Strong technical writing and presentation skills
Responsibilities
- Provide manufacturing oversight to support batch execution and ensure adherence to process parameters and GMP requirements
- Participate in deviation investigations, root cause analysis, and implement corrective and preventive actions (CAPAs)
- Support manufacturing and process development through data analysis, manufacturing document review, and lab-scale studies
- Perform in-process sample testing and manage sample inventory, tracking, storage, and organization
- Maintain accurate documentation in electronic lab notebook (ELN) systems and produce technical reports
- Analyze manufacturing and experimental data using statistical tools and summarize findings for internal stakeholders
- Collaborate cross-functionally with Process Development, Manufacturing, Analytical Development, and Quality teams
- Prepare and present technical data and support interactions with CDMO partners
Education
- BS in Chemical Engineering, Biochemistry, or related discipline with minimum 2 years relevant industry experience
- MS in related discipline (acceptable without industry experience) or equivalent work experience
Benefits
- Hourly range: $48.00/hr - $54.00/hr
- 12-month contract role
- Hands-on experience in clinical-stage vaccine manufacturing and process development
- Cross-functional collaboration and exposure to CDMO partnerships
- Equal opportunity employer
Average salary estimate
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