Manufacturing Process Engineer

Responsibilities

• Identify and mitigate manufacturing issues related to aseptic filling, capping, and lyophilization operations.
• Lead the commissioning, qualification, and validation of process equipment, including FAT and SAT activities.
• Support technical activities for new and existing products, including process optimization and equipment troubleshooting.
• Write and maintain GMP documents such as SOPs, standard test procedures, and engineering batch records.
• Conduct root cause analysis and lead manufacturing investigations and CAPA initiatives.
• Utilize Lean Six Sigma techniques to minimize waste, variability, and human error in the manufacturing process.
• Research new trends and technologies in advanced aseptic filling and manufacturing.

Requirements

• 3-6 years of experience working in a pharmaceutical cGMP environment.
• Proven experience with parenteral processing equipment and operations (formulation, filling, visual inspection, or packaging).
• Hands-on experience managing FAT, SAT, IQ/OQ, and engineering batches.
• Strong proficiency in data-driven root cause analysis and continuous improvement methodologies.
• High standard of technical report writing and ability to explain complex issues to external stakeholders.
• Strong computer skills and the ability to interpret complex technical instructions, math, or diagrams.

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We invest in people who drive progress and create a better tomorrow through operational excellence and a culture of purposeful work.