CQV Engineer - Birmingham, UK
Performs cGMP compliance based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements. Follows client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone-commissioning services for non-FDA regulated clients.
Job Duties and Responsibilities
• Demonstrated/recognised areas of expertise by industry (Sterile, OSD, Biotech, Medical Device), by equipment/systems (lyophilises, autoclaves, packaging, compression/encapsulation, etc.), or by validation activity (process, cleaning, CSV, methods, etc.). Provide working knowledge in the delivery of technical projects in these areas.
• Provide consulting based services in areas of expertise.
• Support, train and provide guidance to validation specialists/engineers in the delivery of C/Q/V services and areas of expertise.
• Write C/Q/V documents following established standards and templates, including but not limited to the following:
1.C/Q/V Master Plans
3.C/Q/V Protocols and Summary Reports
4.Standard Operating Procedures
8.Perform field/site activities including, but not limited to, the following:
9.Execution of commissioning forms and witnessing of vendor start-up and testing.
10.Execution of C/Q/V protocols.
11.Walk down and verification of system drawings (P&IDs, as-builts, etc.)
• Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
• Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
• Coordinate with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
• Audit project deliverables to assure compliance with established standards. Review work of assigned project team.
• Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech and medical device industries.
• Be self-sufficient and effectively work with limited supervision.
• Perform work to meet budget requirements and quality standards. Provide consistent, complete and timely feedback and reports to project leaders, project managers or management of project status and issues.
• Assist the project leader and/or project manager with project management activities, (schedules, attend/lead meetings, maintenance of budgets/deliverables.
• Assist with site auditing and cGMP consulting based services.
• Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is required for a Validation Specialist. Non-BS degrees will be evaluated on a case by case basis.
• Extensive experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation or QA. Experience in the writing and execution of PFC, FC, IQ, OQ and PQ forms and protocols for GMP Utilities, Equipment, Systems and Software.
• Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes.
• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
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