Senior Project Engineer
About the RoleWe are seeking a highly skilled Senior Engineer, Equipment to serve as the technical lead for process equipment supporting Bulk Drug Substance (BDS), Drug Product (DP), and Process Science (PS) systems. This role plays a critical part in ensuring equipment reliability, supporting manufacturing operations, and leading engineering projects from concept through implementation.You will act as a subject matter expert for complex process systems, drive troubleshooting efforts, and lead capital and continuous improvement initiatives in a GMP-regulated environment.Key ResponsibilitiesTechnical LeadershipServe as the engineering technical lead for process systems including:Bioreactors, centrifuges, chromatography skids/columnsPrep and hold tanks, CIP/SIP systemsFilling and packaging equipmentTroubleshoot equipment and process issues from qualification through system releasePerform technical analysis including capacity planning, equipment utilization, and technology assessmentsSupport sustainable design, value engineering, and implementation of new technologiesProject ManagementLead and support CAPEX, OPEX, and continuous improvement (CI) projectsDevelop and review project execution plans and resource estimatesOwn risk assessments for new and existing systemsManage commissioning and startup activities, including:Approval of commissioning reports and protocolsSOP development and reviewProvide technical oversight of contractors and project teamsOptimization & ComplianceDrive continuous improvement and optimization of equipment performanceEnsure compliance with GMP, quality, and EHS standardsLead or support deviation investigations, CAPA, change control, and risk assessmentsAct as System Owner when required (e.g., deviations, out-of-tolerance events)Global Engineering & Best PracticesContribute to the development and implementation of engineering standards and best practicesParticipate in cross-functional and peer reviewsCollaborate with global engineering teams to standardize processes and documentationQualificationsRequired Experience & SkillsMinimum 5+ years of hands-on experience with process equipment/systemsAt least 4+ years in a GMP manufacturing environmentStrong expertise in troubleshooting complex technical issuesProven experience leading:Risk assessmentsRoot cause investigationsEquipment commissioning and qualificationExperience managing change control, deviations, and CAPA processesDemonstrated project leadership (CAPEX or continuous improvement initiatives)Ability to manage contractors and cross-functional stakeholdersExcellent written and verbal communication skillsEducationBachelor’s degree in Engineering with 5–10 years of relevant experience, ORMaster’s degree in Engineering with 5+ years of experience, ORProfessional Engineer (P.E.) licenseWork Environment & Additional RequirementsPrimarily office-based with regular presence on the manufacturing floorAbility to work in a regulated (GMP) environmentOccasional domestic and international travel may be requiredMust be able to meet standard visual and physical job requirementsWhat You’ll BringStrong ability to manage competing priorities in a fast-paced environmentCollaborative mindset with experience working across functions (Manufacturing, Quality, Supply Chain, IT, etc.)Commitment to safety, compliance, and operational excellence