Job Description

Requirements:

• Bachelor’s or Master’s in Mechanical Engineering or related discipline.
• 8+ years in HVAC and utilities design/delivery for GMP or regulated facilities; demonstrated commissioning/qualification support and multi-disciplinary coordination.
• Familiarity with ISO 14644, ISPE Baseline Guides, local mechanical codes, pressure equipment standards; familiarity with AZ Global Engineering Standards, GMP/GEP, SHE, and CPDP.
• Pharmaceutical HVAC: cleanroom design, pressure cascade management, HEPA filtration, temperature/RH control, containment/exhaust strategies, and environmental qualification.
• Mechanical utilities: chilled/hot water, boilers/steam (including clean steam), compressed air/instrument air, vacuum, and inert gas systems; quality testing and compliance.
• Controls integration: BMS control strategies, alarm management, sensor placement, and data integrity considerations in GMP environments.
• Sustainability and resilience: energy modeling, heat recovery, demand control, fault detection/diagnostics, redundancy planning (N+1), and reliability engineering.
• Governance and integration: requirements capture, multi-disciplinary coordination, change/configuration management, and CPDP quality gates.
• Communication and influence: clear documentation, stakeholder alignment, technical mentoring, and constructive challenge to contractors and suppliers.

Pluses:

• Experience with clean steam generation, solvent/toxic exhaust systems, low dewpoint/low RH spaces, cold rooms/freezers, and high efficiency/low carbon solutions (heat pumps, heat recovery).

Job Description:

Insight Global is looking to hire a Mechanical HVAC & Utilities SME to sit in a hybrid environment in Frederick or Gaithersburg, MD. This individual will be responsible for providing technical leadership, governance, and delivery assurance for HVAC and mechanical utilities across the Capital Project Delivery Process (CPDP) stage gate system. This individual will also ensure compliant, reliable, energy-efficient, and maintainable systems that meet Global Engineering, Quality, and SHE requirements, supporting GMP manufacturing environments.

Key Responsibilities Include:

• Technical Leadership: Define HVAC and utilities design basis (environmental classifications, air changes, pressure cascades, temperature/RH, filtration, ventilation/exhaust, utility quality). Translate GMP and operational needs into specs, drawings, and control narratives; ensure segregation, hygienic design, cleanability, and maintenance access. Lead design reviews, manage risks, and drive energy optimization and standardization.
• FEED & Integration: Support early-phase design with site climate/load assessments, capacity planning, utility generation strategies, redundancy (N+1), resilience, and constructability. Coordinate interfaces with process, electrical, BMS/EMS, fire systems, containment, and architecture.
• Supplier Selection: Assess OEMs/integrators for AHUs, chillers, boilers, heat recovery, filtration, clean steam, compressors, and specialty exhaust; recommend based on performance, GMP suitability, lifecycle, and sustainability. Approve handover requirements (as-built docs, O&M manuals, test records, certifications, guarantees, training).
• Compliance & Risk: Embed SHE and GMP requirements in designs (containment, safe access, lockout/tagout, pressure safety, hygienic details). Attend risk assessments; implement mitigations for chemical/toxic exhaust, hot works, confined spaces, Legionella control; address failure modes with redundancy.
• Stakeholder Engagement: Align with Production, QA/QC, Validation, Facilities, EHS, and Digital/OT Security on environmental parameters, alarms, sampling, and reporting. Define design deliverables (airflow diagrams, room data sheets, PFDs/P&IDs, equipment schedules, layouts, control narratives, commissioning plans).
• Commissioning & Qualification: Support TAB, pressure cascade verification, particle counts, recovery tests, filtration integrity, steam/compressed air quality, and alarm testing. Review FAT/SAT and qualification protocols; witness tests; approve stage gates for commissioning and qualification.
• Lifecycle Ownership: Champion energy efficiency, heat recovery, ventilation optimization, water/steam conservation, and predictive maintenance. Define ancillary spaces and spares strategies; ensure ergonomic maintenance access.
• Continuous Improvement: Coach teams on installation quality, duct/piping practices, insulation, filtration, hygienic transitions, and BMS integration. Capture lessons learned and refine best practices for HVAC/utilities and environmental monitoring.

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