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, focusing on process optimization and equipment troubleshooting.
• Write and maintain GMP documents, including SOPs, standard test procedures, and engineering batch records.
• Utilize data-driven root cause analysis and Lean Six Sigma techniques to minimize waste and improve yield.
• Manage manufacturing investigations and CAPA initiatives to ensure compliance and continuous improvement.
• Research new trends and technologies in advanced aseptic filling and manufacturing.

Requirements

• Bachelor's Degree in a STEM field (Science, Technology, Engineering, or Mathematics).
• 3-6 years of experience working within a Pharma cGMP environment.
• Exposure to parenteral processing equipment and operations (formulation, filling, visual inspection, and packaging).
• Proven ability to manage on-the-floor activities such as FAT, SAT, IQ/OQ, and engineering batches.
• Strong computer skills with the ability to support the operation of Aseptic Filling Isolator technology.
• Experience in data-driven root cause analysis and continuous improvement prioritization.

Preferred Qualifications

• Ability to explain complex technical issues to external customers and regulatory agencies.
• High standard of technical report writing.
• Advanced reasoning skills to define problems, collect data, and draw valid conclusions.
• Ability to interpret complex technical instructions in mathematical or diagrammatic forms.

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, dedicated to bridging the gap 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.