Job Title: CQV Mechanical Engineer
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About the Role:
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We are seeking an experienced mechanical engineer to support our CQV activities for the installation and integration of heat pump equipment and boiler packages on-site.
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The successful candidate will collaborate closely with project engineering, CQV, quality assurance, and operations teams, with a focus on delivering qualified utility systems to support four main operational areas (production, fill-finish, packaging, and warehousing) as well as ancillary spaces (such as laboratories, maintenance, and utility buildings).
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Responsibilities:
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* Lead and support CQV activities for heat pump and boiler systems.
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* Design Qualification (DQ) review.
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* Commissioning protocol generation and execution (FAT, SAT).
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* Verification of mechanical installation (piping, pumps, exchangers, valves).
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* System walkdowns and punch list resolution.
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* Review and approval of P&IDs, datasheets, isometrics, and turnover packages.
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* Review and contribute to the design and layout of mechanical systems.
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* Oversee vendor equipment delivery, installation, and field verification.
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* Interface with building management systems (BMS/EMS) for control and monitoring setup.
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* Support tie-in and integration planning with existing utility networks (steam, hot water, chilled water, etc.).
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* Generate and review engineering and CQV documentation per site GMP standards.
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* Mechanical Completion documentation.
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* Utility Impact Assessments.
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* Risk assessments and URS traceability.
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* Turnover package compilation and support handover to Operations.
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* Liaise with project teams, contractors, vendors, validation, and QA to ensure mechanical systems are installed and qualified per cGMP and safety requirements.
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* Participate in project and CQV meetings, tracking action items to resolution.
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Requirements:
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* Bachelor's degree in Mechanical Engineering or related discipline.
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* 5+ years of experience in mechanical systems implementation on pharmaceutical/biotech facilities.
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* Experience in CQV for utility systems (preferably boilers, heat pumps, HVAC, chilled/hot water).
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* Strong understanding of GMPs, GEP.
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* Familiarity with ASME B31.3, PED, and relevant mechanical/utilities standards.
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* Previous experience with green or energy-efficient technology integration (e.g., heat pumps) desirable.
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* Ability to read and redline P&IDs, isometrics, and mechanical schematics desirable.
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* Understanding of site utility systems and their impact on GMP manufacturing desirable.
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Benefits:
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This role offers the opportunity to work on a dynamic project-based team with potential for shift or weekend work during key CQV phases.
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Others:
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Please note that this job may require field work including equipment inspections and system verifications.
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