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.
KEY ACTIVITIES AND RESPONSIBILITIES
Write C/Q/V documents following established standards and templates, including Commissioning Forms, C/Q/V Protocols and Summary Reports, Standard Operating Procedures, Impact Assessments, Specifications (URS/FRS/DDS), FATS/SATs
Execution of commissioning forms and witnessing of vendor start-up and testing.
Execution of C/Q/V protocols.
Walkdown 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.
Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services
Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested.
Bachelor of Science in Engineering.
2 or more years of relevant experience CQV experience
Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software a plus.
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 helpful