Job Title: Commissioning and Qualification Specialist
Location: Cork, Ireland
Job Summary:
The Commissioning and Qualification Specialist will be responsible for all activities required to support project commissioning and qualification in the Technical Compliance Team. The role includes preparation and execution of commissioning and qualification protocols for site systems/equipment.
Main Responsibilities:
* Contribute to all aspects of C&Q from design through to commissioning and qualification completion.
* Support and participate in the design of systems and equipment to ensure compliance with cGMP requirements.
* Prepare C&Q protocols as required (e.g., URSs/SRSs, Plans, Impact Assessments, DQ, IQ, OQ, PQ protocols and Reports).
* Review and approve documents prepared by contractor organisations (e.g., vendor SATs, FATs, commissioning protocols, project change controls/notifications).
* Execute C&Q protocols as required.
* Compile relevant documentation from vendors, contractors, and other departments for inclusion in protocols/reports.
* Complete activities/deliverables in accordance with each project's site change control required deliverables (from a C&Q perspective).
* Track and support the resolution of Commissioning punch list items and Qualification deviations during the C&Q execution phase.
* Prioritize C&Q activities in line with site and project schedules.
* Coordinate C&Q activities with project engineering, construction, and site operations activities.
* Coordinate C&Q activities with contractors and vendors as required.
* Coordinate C&Q document reviews and approvals.
* C&Q System/Equipment/Components as per site procedures.
* Strong collaboration with Quality Department.
Key Requirements:
* Minimum 5+ years experience in the Pharmaceutical (API) Industry.
* Experience of commissioning and qualifying some of the following systems: Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, Autoclaves, and Isolators and clean/Grey utility systems (such as purified water, water for injection, clean steam, HVAC, Process Gases, Steam, and Condensate systems etc.).
* Experience preparing and executing commissioning and qualification protocols and reports.
* Knowledge and experience of Project Delivery Processes (PDP).
* Knowledge and experience of current Good Engineering Practices (cGEP).
Desirable Skills:
* Experience with use of ABB Industrial IT control systems.
* Experience of Pharmaceutical facility local and controlling instrumentation.
* Extensive experience of commissioning and qualification of production systems, utilities, and facilities and change management.
* Experience of working within a Technical Compliance/Project team in a multinational corporate environment.
* Experience of ASTM 2500 and/or Risk-Based Qualification approach.