Process Engineer

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.

• 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.

• 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 washers
• Cappers
• Integrity testing systems
• Auto syringe assembly
• Autoclaves
• Experience 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.