Project Engineer

Project EngineerEngineeringFremont, California, USAdded - 14/05/2026We are seeking a Senior Equipment Engineer (Project Manager) to support biopharmaceutical manufacturing operations within Bulk Drug Substance (BDS), Drug Product (DP), and Process Science systems. This individual will serve as the technical lead for process equipment, supporting troubleshooting, commissioning, qualification, CAPEX/continuous improvement projects, and GMP manufacturing operations.The ideal candidate will have strong hands-on experience with upstream/downstream process equipment in a GMP-regulated environment and be comfortable leading technical investigations, change controls, deviations, and startup activities.Location: Fremont, CaliforniaContract Length: 6+ Month ContractSchedule: Monday-Friday | 40 hours/weekPay Rate: $95.00-$110.00/hour DOEKey ResponsibilitiesServe as technical lead for process equipment and manufacturing systemsTroubleshoot equipment/process issues during qualification, startup, and productionLead and support CAPEX, OPEX, and continuous improvement projects from feasibility through handoffSupport commissioning, startup, qualification, and system release activitiesOwn or support deviations, CAPAs, change controls, and risk assessmentsAct as System Owner for manufacturing/process equipment as neededReview and approve SOPs, protocols, commissioning documentation, and project execution plansOversee contractors and provide technical guidance during project executionEnsure compliance with GMP, FDA, OSHA, quality, and safety requirementsCollaborate cross-functionally with Manufacturing, Quality, Validation, Facilities, Automation, and Engineering teamsEquipment & Systems ExperienceHands-on experience supporting and troubleshooting process equipment including:BioreactorsCentrifugesChromatography skids and columnsPrep and hold tanksCIP/SIP systemsFilling and packaging equipmentQualificationsBachelor's degree in Engineering with 5-10 years of related experience OR Master's degree with 5+ years of experienceMinimum 4+ years of experience in GMP manufacturing environmentsStrong technical knowledge of biopharmaceutical process equipment and systemsExperience leading investigations, risk assessments, startup/commissioning, and qualification activitiesExperience owning deviations, CAPAs, and change controlsProven project leadership experience supporting CAPEX or continuous improvement initiativesExcellent communication and cross-functional collaboration skillsThis job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!#LI-CS1We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.