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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Commissioning, Qualification and Validation Engineer


Reference:SMC72956 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Process Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties

  • As such you will be executing with a view to leveraging testing from Commissioning and Qualification to PQ where possible.
  • Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
  • Implementing the requirements as outlined in the site / C&Q and project Validation Master Plan.
  • Coordination of engineering sub-teams in the assigned suite during execution of IQ/OQ / Cycle Development & Validation activities.
  • Authoring and reviewing standard operating procedures and technical reports including IOC/ IOQ & PQ protocols.
  • Technical owner of Commissioning protocols, Qualification protocols and input to Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Supporting regulatory submissions as required.
  • Input to Change Management process for Equipment introduction within the assigned suite for qualification / validation up to PQ stage.
  • Effective application of LeanSixSigma and Change Management tools in the Validation group by:
  • Leading by example in achieving results by using industry standard tools and processes
  • Facilitate problem solving & risk assessment (FMEA) projects/meeting.
  • Make problems visible and strive for continuous improvement.
  • Serving as a key member during internal audits and external inspections/audits.
  • Support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).
  • Keep up to date with scientific and technical developments, best practices and attend seminars as required.
  • Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

Education & Experience

  • Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects
  • SME on Equipment Validation on any of; Parts Washer / Autoclaves / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities - Transfer Panels & Formulation / Visual Inspection/ Single Use Technologies

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.