Senior Process Engineer – Aseptic Fill-Finish & Project Lead

Role:
Mid/Senior Process Engineer (Based on Experience)

Duration: 12+ Months

We are seeking a Mid/Senior Process Engineer to support a facility expansion project currently in the design phase. The ideal candidate will have hands-on experience leading projects from design through implementation, with a strong background in aseptic fill-finish manufacturing.

Key Responsibilities:

• Support facility expansion and equipment implementation projects.
• Prepare and manage RFPs, evaluate vendor quotations, and coordinate with external equipment suppliers.
• Conduct design reviews based on internal User Requirement Specifications (URS).
• Collaborate with cross-functional teams and external vendors throughout the project lifecycle.
• Drive process improvements and ensure successful equipment installation and startup.

Required Experience:

• Proven experience in fill-finish manufacturing is mandatory.
• Hands-on experience with:
• Vial Washers
• Cappers
• Container Closure Integrity Testing (CCIT)
• Automated Syringe Assembly
• Autoclaves
• Experience supporting FAT/SAT activities.
• Strong process engineering and equipment design experience.
• Demonstrated experience managing projects from design through implementation.
• Process improvement and continuous improvement expertise.

Note: This is not a CQV or Validation Engineer role. We are specifically looking for a true Process Engineer with hands-on process design, equipment, and fill-finish manufacturing experience.