Commissioning, Qualification and Validation 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.

• 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