Process Change Manager

1 week ago


Cork, Cork, Ireland beBeeChangeControl Full time €60,000 - €90,000
Change Control Specialist

We are seeking a skilled professional to oversee process changes, ensuring compliance and efficiency in our manufacturing operations.

  • Support vaccine drug substance and/or drug product processes to ensure regulatory requirements are met.
  • Collaborate with cross-functional teams to drive successful commercial manufacture and meet organizational goals.
  • Develop and implement process change control documentation, technical communications, and risk management strategies.
  • Provide technical oversight and planning support for complex partnership models.
  • Assess viability of technology in proposed process configurations and verify adherence to required standards.
  • Lead team efforts to identify and mitigate partner risks, ensuring timely resolution of production issues.
  • Review process change requests, deviations, and Master Batch Record changes to ensure technical compliance.
Requirements:
  • Bachelor's degree in Engineering or applicable Science is required. An advanced degree is preferred.
  • Experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is essential.
  • Excellent leadership, collaboration, change management, interpersonal, analytical skills, and engagement as a team player with dependable interpersonal and communication skills.


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