CQV Engineer I

Key Responsibilities

• Perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as defined in project agreements.
• Follow IPS and client standards and requirements, good industry practices for C/Q/V services, and regulatory requirements.
• May perform standalone commissioning services for non-FDA-regulated clients.
• 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
• Perform field/site activities, including:
• Attend and witness FATs and SATs.
• Execute commissioning forms and witness vendor start-up and testing.
• Execute 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, etc.
• Assist in deviation investigation and resolution of problems and issues encountered during field execution.
• Work with the Project Delivery department or CM for start-up and vendor testing, witnessing and troubleshooting 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 IPS Best Practices and SOPs for the 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 on project status and issues.

Requirements & Tech Stack

• Bachelor of Science in Engineering.
• Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
• Must be able to stand, sit, and walk for prolonged periods, stoop, kneel, crouch, and crawl as required.
• Must be able to lift and move objects weighing up to 50 pounds and climb ladders as necessary.
• Ability to work in both indoor and outdoor environments, which may include exposure to varying working conditions.
• Ability to adhere to strict cleanroom gowning protocols.
• Up to 100% travel as required by the assigned project.
• Position may be assigned to the client site for an extended period.
• Overnight travel or staying in the city of the client’s location is possible.
• Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
• Must have access to reliable transportation.
• This is a safety-sensitive position for field work at client sites.

Qualifications

• 0-2 years of relevant experience.
• Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
• General exposure and experience in a GMP/Validation discipline with knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and their relation to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.