Manufacturing Process Engineer

PCI Pharma Services · Bedford, NH

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Role summary

Manufacturing Process Engineer will identify and mitigate production issues in aseptic filling and related operations through process improvement and engineering methods. The role focuses on optimizing existing processes, leading equipment qualification and validation activities, and supporting manufacturing teams at a pharmaceutical contract manufacturing facility.

What they're looking for

3-6 years pharmaceutical cGMP manufacturing experience or equivalent education/experience combination
Experience with parenteral processing equipment including filling, visual inspection, and packaging
Ability to lead teams through FAT, SAT, IQ/OQ, and engineering batch activities
Strong data-driven root cause analysis and continuous improvement experience
Intermediate to advanced computer skills for aseptic filling isolator operation and support systems
Ability to explain complex technical concepts to external customers and regulatory agencies
Proficient written and verbal communication skills at professional level

What you'll be doing

Support technical activities for new and existing products including process optimization, troubleshooting, and validation
Gather and analyze manufacturing data to minimize waste, variability, and improve yield and efficiency
Write standard operating procedures, standard test procedures, batch records, and GMP documentation
Lead commissioning of equipment including change controls, FAT/SAT activities, and staff training
Lead manufacturing investigations and corrective action initiatives; approve validation protocols as needed

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Date posted2 days ago

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