Manufacturing Process Specialist

5 days ago


Dublin, Dublin City, Ireland PQE Group Full time

PQE Group is a leading player in the Pharmaceutical and Medical Device industries, boasting an extensive presence across Europe, Asia, and the Americas. With 40 subsidiaries and over 2000 employees, we have established ourselves as a trusted partner for clients worldwide.

Job Description

We are seeking a highly skilled Design Control Specialist to join our team in Dublin, Ireland. As a key member of our staff, you will be responsible for ensuring the seamless transfer of manufacturing processes from our R&D department to commercial manufacturing sites.

Main Responsibilities:
  • Process Support: Provide technical support for the transfer of manufacturing processes, adhering to our design control process and relevant regulatory requirements such as ISO 13485 and 21 CFR 820.
  • Transfer Plan Development: Develop and deliver a comprehensive Technical Transfer Plan and Report outlining the transfer of all required deliverables, including equipment requirements and manufacturing and testing specifications.
  • Interface Management: Serve as the primary interface between our R&D and commercial manufacturing sites during device/combination product development, providing support for troubleshooting all device-related issues and investigations.
  • Knowledge Transfer: Drive knowledge transfer and training on relevant technical transfer activities to the commercial site.
  • Change Control Management: Manage, review, and approve change controls issued from the commercial site or from our R&D department that may impact the device/combination product.
  • Manufacturing Process Understanding: Develop and maintain manufacturing process understanding through the use of tools such as Cause and Effect Analysis, providing linkage to all aspects of manufacturing and identifying potential failures.
  • Troubleshooting: Provide technical support and serve as a technical subject matter expert on-site as required at suppliers or manufacturing sites for device-related complaints, supporting device-related investigations to root cause and establishing appropriate corrective actions.
  • Technical Reviews: Collaborate with Device Program Teams in support of Technical Reviews, Technology Transfers, and Design Transfers across our portfolio.
  • Routine Program Review: Contribute to the Routine Program Review process.
About You:
  • Educational Background: A degree in Engineering or Science is required.
  • Experience: Previous experience in Technical Transfer and/or Technical Support in high-volume GMP manufacturing environments for devices and/or combination products is essential.
  • Documentation Skills: Proven ability to author technical reports and produce high-quality documentation within a regulatory-controlled GMP environment.
  • Regulatory Knowledge: Familiarity with ISO 13485 and FDA 21 CFR Part 820 Design Control requirements is an advantage.


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