Senior Production Process Engineer

2 weeks ago

Sligo, Sligo, Ireland beBeeTechnicalTransfer Full time €60,000 - €100,000
Job Title: Technical Transfer Team Lead

This role is pivotal in our organization, overseeing the technical transfer production team. A successful candidate will possess experience in NPI and production support within the biotechnology and/or pharmaceutical sector.

Key Responsibilities:

  • Lead, motivate and develop the team, providing technical expertise and leadership for investigation and resolution of process deviations, root cause analysis, CAPAs, process improvements, review and approval of change controls.
  • Provide team leadership, setting work goals, controlling and meeting goals, professional and personal development of team members.
  • Engage in high-level on-the-floor activity day-to-day to support production issues.
  • Drive product-related problem-solving initiatives – foster a culture of inquiry.
  • Understand the science of process including process flows, CPPs, historical failures.
  • Conduct process monitoring/trending.
  • Support QA with generation and closure of annual product reviews.
  • Apply continuous improvement tools for incremental change.
  • Implement new production methods, Technology transfer: Examine production methods prior to their transfer to production, including validation (when needed).
  • Follow-up and training of production teams.

Requirements:

  • Minimum 5 years experience in the biotechnology and/or pharmaceutical industry, with experience of new product introductions and product support.
  • Knowledge of the processes and equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals.
  • Experience in authoring, review and execution of validation studies and reports is essential.
  • Experience with vaccines would be advantageous particularly in the area of product development and stewardship.
  • Ability to prioritize workload for self and reports, experience coaching and mentoring a team.
  • Demonstrated ability in leading root cause analysis and effective investigation practices.

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