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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Commissioning and Qualification Engineer


Reference:SMC4569 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Validation Coordinator

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

  • Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests. Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
  • Act as C&Q SME on the equipment within the area assigned.
  • 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
  • Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus

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