The role of a Project Engineer is crucial in supporting the delivery of capital and site-based projects within a highly regulated pharmaceutical manufacturing environment. This position requires an intermediate-level engineer who has developed a solid foundation in GMP environments and is now seeking to broaden their experience across utilities, process support systems, and equipment projects.
Key Responsibilities
1. Support the execution of equipment, facility, and clean utility projects from concept and detailed design through installation, commissioning, and final handover.
2. Assist with upgrades and modifications to clean utilities including WFI (Water for Injection), Purified Water (PW), Clean Steam (CS), Clean Compressed Air (
3. Support projects involving production and support equipment such as vessels,solid-mounted systems,HVAC Chillers,Building Services.
/li/XMLize activities with Engineering Operations Quality Automation external vendors ensure project milestones are achieved documentation & gmp compliance Prepare review maintain URS Functional/Design Specifications Commission Plans Test Scripts Handover Packages Ensure project activities executed accordance gmp fda internal quality standards Supporting audit inspection readiness Participate risk assessments impact assessments change control throughout lifecycle commission start-up troubleshooting Actively supportservices processes qualification execute test scripts document results system start-up assist troubleshoot encountered during phases working closely vendors SMEs Support deviation resolution punch-list closeout transition operations Experience Qualifications 35 years engineering experience gmp-regulated pharmaceutical life sciences environment Hands-onExperienceCleanUtilitiesFacilitiesProcessSupportSystems WFI PW CS CCA Working knowledgeprojectlifecyclephases includerequirementdefinitiondesigninstallationcommissionhandovertime preparingmaintainingechnicalGMDocumentationqualificationinvestigationprocesses advantages SkillsCompetencies StrongOrganizationalSkills ability manage multiple workstreamspriorities PracticalHandsOnapproach problem solving particularly during commission startup SoundUnderstandingGMPFDAregulatoryrequirements applyutilitiesmanufacturing SkillsHVAC Utilities CleanupTitliesProjectEngineeringManagementCIPBenefitsSiteParking