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Details
Commissioning, Qualification and Validation Engineer
Reference: | SMC72956 | Location: |
Carlow |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | 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.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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