Job Description:
The Commissioning and Qualification Engineer will be responsible for supporting all activities required to ensure project commissioning and qualification. This includes the preparation and execution of commissioning and qualification protocols for site systems/equipment such as Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, Autoclaves, and Isolators.
This role involves coordinating with various departments, including Project Engineering, Construction, and Site Operations. The ideal candidate should have 5+ years of experience in the API industry, including several years working in Commissioning and Qualification of equipment.
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Key Responsibilities:
* Provide input into 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., URS/SRS, Plans, Impact Assessments, DQ, IQ, OQ, PQ protocols, and Reports).
* Review and approve documents prepared by contractor organizations.
* 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.
* Track and support the resolution of Commissioning punch list items and Qualification deviations during the C&Q execution phase.
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Required Skills and Qualifications:
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.
* Extensive experience of commissioning and qualification of production systems, utilities, and facilities and change management.
Knowledge and experience of Project Delivery Processes (PDP) and current Good Engineering Practices (GEP).
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Benefits:
Competitive salary and benefits package.
Opportunities for career growth and professional development.
A dynamic and collaborative work environment.