Associate Engineer II (Contract), Polysaccharide Manufacturing

About the role

Vaxcyte is seeking an Associate Engineer II to join the Polysaccharide Clinical Manufacturing/Process Development team. This role provides technical support for manufacturing activities in collaboration with CDMO partners, while also contributing to process development and process validation efforts.

Responsibilities

• Provide remote manufacturing (MFG) oversight to support batch execution, ensuring adherence to process parameters and GMP requirements
• Participate in deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs)
• Provide technical support for MFG and process development through data analysis, MFG document reviews, and supporting lab scale studies
• Perform in-process sample testing to support monitoring of MFG process performance and understanding
• Manage sample inventory, including tracking, storage, and organization of manufacturing samples
• Maintain accurate and timely documentation in electronic lab notebook (ELN) systems
• Analyze manufacturing and experimental data using statistical tools (e.g., JMP) and summarize findings in technical reports
• Collaborate with cross-functional teams including Process Development, Manufacturing, Analytical Development, and Quality
• Prepare and present technical data to internal stakeholders and support interactions with CDMO partners

Requirements

• BS in Chemical Engineering, Biochemistry, or a related discipline, with minimum 2 years of relevant industry experience. MS without experience; or equivalent work experience.
• Experience or exposure to GMP manufacturing environments and process development activities
• Hands-on experience with in-process analytical techniques, including colorimetric and enzymatic assays
• Familiarity with upstream and downstream processing technologies, such as fermentation, UF/DF, depth filtration, and chromatography
• Experience supporting technology transfer, scale-up, or CDMO-based manufacturing is preferred
• Understanding of deviation investigations and root cause analysis methodologies
• Familiarity with statistical analysis tools (e.g., JMP) is preferred
• Experience using electronic lab notebook (ELN) systems is a plus
• Strong technical writing, data analysis, and communication skills

Qualifications

• BS in Chemical Engineering, Biochemistry, or a related discipline, with minimum 2 years of relevant industry experience. MS without experience; or equivalent work experience.
• Experience or exposure to GMP manufacturing environments and process development activities
• Hands-on experience with in-process analytical techniques, including colorimetric and enzymatic assays
• Familiarity with upstream and downstream processing technologies, such as fermentation, UF/DF, depth filtration, and chromatography
• Experience supporting technology transfer, scale-up, or CDMO-based manufacturing is preferred
• Understanding of deviation investigations and root cause analysis methodologies
• Familiarity with statistical analysis tools (e.g., JMP) is preferred
• Experience using electronic lab notebook (ELN) systems is a plus
• Strong technical writing, data analysis, and communication skills

Skills

• Technical writing
• Data analysis
• Communication skills

Benefits

• Equal Opportunity Employer

Pay

• Hourly Range: $51.00/hr. - $56.00/hr.

Schedule

• Expected Contract Length: 12months