Process Optimization Professional

3 days ago

Cork, Cork, Ireland beBeeChangeControl Full time €90,000 - €120,000
Job Opportunity

Our organization is seeking a highly skilled professional to fill the role of Change Control Specialist. This individual will play a critical role in ensuring the successful support and commercial manufacture of our products.

Key Responsibilities:
  • Provide technical expertise for vaccine drug substance and/or drug product processes, including on-site support within the manufacturing facility.
  • Support various activities such as Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ).
  • Collaborate across multiple functions within the organization to ensure successful support and commercial manufacture.
  • Author process change control documentation, technical communications, and process risk management.
  • Oversee complex partnership models, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
  • Lead team identification and assessment of partner risks and develop mitigation plans.
  • Provide manufacturing process support to External Partners to resolve production issues and provide guidance on process and capacity optimization.
  • Support/Coordinate investigations with appropriate interface with other impacted manufacturing sites.
  • Review External Partner process change requests, deviations, and Master Batch Record changes.
Requirements:
  • Bachelor's degree in Engineering or applicable Science is required. Advanced degree in Engineering, Science, or Business is preferred.
  • Experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is required.
  • Excellent leadership, collaboration, change management, interpersonal, analytical skills, and engagement as a team player with dependable interpersonal and communication skills is required.

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