Process Engineer
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We are seeking an experienced Senior Process Engineer to support a pharmaceutical facility expansion project. This is an exciting opportunity to lead process engineering activities from design through implementation, working on state-of-the-art fill-finish manufacturing systems.Key Responsibilities:Lead process engineering activities for facility expansion projects.Support equipment design, procurement, vendor selection, and technical reviews.Develop and review process documentation, including URS, P&IDs, and equipment specifications.Collaborate with cross-functional teams and external vendors throughout the project lifecycle.Support technology transfer, process scale-up, and manufacturing readiness.Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).Drive process improvements and continuous optimization initiatives.Support commissioning, qualification, and validation activities while ensuring cGMP compliance.Required Qualifications:Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related discipline.3+ years of relevant pharmaceutical process engineering experience.Hands-on experience supporting projects from design through implementation.Strong knowledge of fill-finish manufacturing, including vial and syringe filling processes.Experience with:Vial washersFillersCappersIntegrity testing systemsAuto syringe assemblyAutoclavesExperience with equipment procurement, RFP preparation, vendor management, and design reviews.Experience performing FAT/SAT activities.Strong process improvement and troubleshooting skills.Working knowledge of cGMP/FDA regulations and pharmaceutical manufacturing standards.