Purpose
We are seeking an experienced Mechanical Engineer to support the Commissioning, Qualification, and Verification (CQV) efforts for the installation and integration of heat pump equipment and two boiler equipment packages on a GMP pharmaceutical manufacturing site.
The role will involve close collaboration with project engineering, CQV, quality assurance, and operations teams, focusing on delivering qualified utility systems to support four main operational areas (e.g., production, fill-finish, packaging, warehousing) and ancillary spaces (e.g., labs, maintenance, and utility buildings).
Responsibilities
CQV & Project Support
Lead and support CQV activities for heat pump and boiler systems, including:
Design Qualification (DQ) review
Commissioning protocol generation and execution (FAT, SAT,)
Verification of mechanical installation (piping, pumps, exchangers, valves)
System walkdowns and punch list resolution
Review and approval of P&IDs, datasheets, isometrics, and turnover packages
Engineering Implementation
Review and contribute to the design and layout of mechanical systems
Oversee vendor equipment delivery, installation, and field verification
Interface with building management systems (BMS/EMS) for control and monitoring setup
Support tie-in and integration planning with existing utility networks (steam, hot water, chilled water, etc.)
Documentation & Compliance
Generate and review engineering and CQV documentation per site GMP standards, including:
Mechanical Completion documentation
Utility Impact Assessments
Risk assessments and URS traceability
Turnover package compilation and support handover to Operations
Cross-functional Collaboration
Liaise with project teams, contractors, vendors, validation, and QA to ensure mechanical systems are installed and qualified per cGMP and safety requirements
Participate in project and CQV meetings, tracking action items to resolution
Qualifications & Experience
Bachelor's degree in Mechanical Engineering or related discipline
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,
Familiarity with ASME B31.3, PED, and relevant mechanical/utilities standards
Excellent problem-solving, communication, and technical writing skills
Desirable Skills
Previous experience with green or energy-efficient technology integration (e.g., heat pumps)
Ability to read and redline P&IDs, isometrics, and mechanical schematics
Understanding of site utility systems and their impact on GMP manufacturing