6518 - Service Order CQV Engineer / Validation Engineer

Service Order CQV Engineer Responsibilities:

• Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System boundary definition, Risk Assessment, Traceability matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, Turnover documentation

• Author and execute technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client’s quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards 

• Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support

• Manage and work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits

• Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope

Requirements:

• A minimum of a Bachelor’s degree in an Engineering or Scientific degree 

• 1-3 years’ experience in GMP regulated environment 

• Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls) 

• Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls 

• Intermediate to Expert (Senior and Lead) knowledge of FDA regulations, ISPE guidelines and ISO standards including Good Documentation Practice (GDP) in pharmaceutical environment 

• ASTM-E2500