Validation Specialist
We are seeking a highly skilled Validation Specialist to lead and support CQV activities for heat pump and boiler systems. This includes design qualification review, commissioning protocol generation and execution, verification of mechanical installation, system walkdowns and punch list resolution, and review of P&IDs, datasheets, isometrics and turnover packages.
Responsibilities:
1. Conduct thorough design qualification reviews to ensure compliance with site GMP standards
2. Develop and execute commissioning protocols for heat pump and boiler systems, including FAT and SAT procedures
3. Verify the correct mechanical installation of piping, pumps, exchangers, and valves to prevent defects and inefficiencies
4. Perform system walkdowns and resolve punch lists in a timely manner to minimize delays
5. Review and approve P&IDs, datasheets, isometrics, and turnover packages to ensure accuracy and completeness
6. Collaborate with cross-functional teams to design and layout mechanical systems that meet site requirements
7. Oversee vendor equipment delivery, installation, and field verification to ensure quality and reliability
8. Interface with building management systems (BMS/EMS) for control and monitoring setup to optimize system performance
9. Support tie-in and integration planning with existing utility networks to minimize disruptions
10. Generate and review engineering and CQV documentation per site GMP standards, including Mechanical Completion documentation, Utility Impact Assessments, Risk assessments, and URS traceability, as well as Turnover package compilation and support handover to Operations
Requirements & Qualifications:
* Bachelor's degree in Mechanical Engineering or related field
* At least 5 years of experience in mechanical systems implementation on pharmaceutical/biotech facilities
* Experience in CQV for utility systems, preferably boilers, heat pumps, HVAC, chilled/hot water
* Strong understanding of GMPs, GEP, and relevant mechanical/utilities standards
* Previous experience with green or energy-efficient technology integration, such as heat pumps
* Ability to read and redline P&IDs, isometrics, and mechanical schematics, as well as understand site utility systems and their impact on GMP manufacturing
About Us:
We are a dynamic organization dedicated to delivering high-quality products and services. Our team members are passionate about what they do and strive for excellence in every aspect of our work.