Pharma Process Engineering Lead: Scale-Up & Innovation
Fresenius Kabi USA, LLC
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Benefits offered by this job
Job summary
Fresenius Kabi USA, LLC is seeking a Senior Process Engineer to lead a cross‑functional team in designing and delivering complex parenteral formulation processes. You will direct engineering design, scale‑up, and technology transfer for lipid emulsions, lyophilization, and other sterile products.
The role requires strong project management, 5+ years in pharmaceutical processing, and experience with validated systems.
Qualifications
- BS in chemical, process or pharmaceutical engineering or related field; advanced degree strongly preferred.
- 5 years of professional experience in pharmaceutical complex formulations and manufacturing technologies.
- Experience with validated manufacturing process systems and CIP/SIP is desired.
Responsibilities
- Innovate and develop new or alternative processing technologies for complex formulations.
- Lead engineering design for lipid emulsions, lyophilization, and other parenteral formulations.
- Coordinate URS, IQ/OQ, and installation for high‑pressure homogenization, microfluidization, and sterilization equipment.
- Manage technology transfer and scale‑up activities from lab to production.
- Ensure projects stay within budget and meet GMP compliance and safety standards.
Skills
Education
Tools
Job description
Fresenius Kabi USA, LLC is seeking a Senior Process Engineer to lead a cross‑functional team in designing and delivering complex parenteral formulation processes. You will direct engineering design, scale‑up, and technology transfer for lipid emulsions, lyophilization, and other sterile products.
The role requires strong project management, 5+ years in pharmaceutical processing, and experience with validated systems.
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