Netherlands Job Openings
IPS-Integrated Project Services
Validation Engineer
Somerset
FULL TIME
September 18, 2024
In this role, you will perform c GMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements.
What You'll Do
-
Write C/Q/V documents following established standards and templates, including but not limited to the following:
- 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, but not limited to, the following:
- Attend and witness FATs and SATs as a representative of IPS clients
- Execution of commissioning forms and witnessing 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, etc.
- 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
- 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 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, of project status and issues, as requested.
- Bachelor of Science in Engineering.
- 2+ years of relevant experience.
- Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
- Proficiency with Microsoft Office Suite.
- General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and c GMP regulations within the E.U. and U.S. FDA.
- Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
- This position will have up to 100% travel to the site, or as required by the assigned project.
- You may be assigned to a client site for an extended period of time.
- Overnight travel or staying in the city of the Client’s location is possible depending on the assignment.
- Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
- You will visit Client sites and will be required to adhere to stated safety rules.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Attention Search Firms / Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via email, the Internet, or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.
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