Associate Engineer II, Polysaccharide Manufacturing
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance (Conjugation), and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is seeking an Associate Engineer II with experience or strong foundational knowledge in vaccine or biologics process development and manufacturing to join the Polysaccharide Clinical Manufacturing/Process Development team.
The candidate will provide technical support for manufacturing activities in collaboration with CDMO partners, while also contributing to process development and process validation efforts. The position requires laboratory presence (>50%) and the ability to independently execute and document experiments, analyze data, and communicate results through technical reports and presentations. The successful candidate will collaborate cross-functionally and may interface with external CDMO partners to support manufacturing campaigns and process transfers.
Essential Functions:
- 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
Reports to: Senior Engineer, MSAT Polysaccharide
Location: San Carlos, CA
Expected Contract Length: 12months
Hourly Range: $48.00hr - $54.00/hr.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.