Biotechnology Engineer Position
This contract position is responsible for all activities required to support project commissioning and qualification in the pharmaceutical industry.
The role of the C&Q Engineer includes 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 and clean / grey utility systems.
The ideal candidate would have 5+ years experience in API industry including several years working in Commissioning and Qualification of equipment.
Responsibilities:
* Provide input into all aspects of C&Q i.e. from design through to commissioning and qualification completion.
* Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements.
* Prepare C&Q protocols as required (e.g. URS?s / SRS?s, 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 projects 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.
* Co-ordinate C&Q activities with project engineering, construction and site operations activities.
* Co-ordinate C&Q activities with contractors and vendors as required.
* Co-ordinate C&Q document reviews and approvals.
* C&Q System / Equipment / Components as per site procedures.
* Strong collaboration with Quality Department.
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 (GEP).
Preferred 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.