Senior Process Engineer

Trinity's Engineering & EHS Workforce Solutions business line is seeking a Sr. Process Engineer on behalf of our Life Sciences/Built Pillar. This position is project based with an estimated duration of one year. Project duration is not guaranteed. Extension is possible, though not guranteed. The role W-2 and fully benefits eligible including Paid Time Off (PTO), holiday pay, Medical, Dental, Vision benefits, and 401K plus company match.

An experienced Sr. Process Engineer with 10+ years of experience will be managing cleanroom and controlled-environment projects within the pharmaceutical, biotechnology, or medical device industries. The select candidate will lead projects from design through construction, commissioning, qualification, and turnover, with responsibility for scope, schedule, budget, safety, quality, and stakeholder coordination. The ideal candidate will have direct experience delivering GMP cleanroom renovations, expansions, and/or new-build facilities, with a strong understanding of cleanroom HVAC systems, architectural finishes, utilities, equipment integration, construction sequencing, and commissioning/qualification requirements.

Key Responsibilities

• Lead cleanroom capital projects through detailed design, procurement, construction, commissioning, qualification, startup, and turnover.
• Develop and manage project scope, execution plans, budgets, schedules, milestones, risks, and change control.
• Coordinate multidisciplinary teams including Architectural, HVAC/Mechanical, Electrical, Process, Automation, Utilities, Validation/CQV, EHS, Quality, Manufacturing, and Facilities.
• Manage cleanroom design requirements including room classifications, pressure cascades, airflow/ACH, temperature and humidity, HEPA filtration, personnel/material flows, finishes, and equipment layouts.
• Review design packages, drawings, specifications, P&IDs, equipment submittals, RFIs, change orders, and contractor proposals.
• Manage general contractors, trade contractors, equipment vendors, design firms, and other project partners.
• Coordinate construction activities within or adjacent to operating GMP facilities, including shutdowns, tie-ins, temporary controls, contamination-control measures, and construction sequencing.
• Ensure projects comply with applicable GMP requirements, client engineering standards, cleanroom requirements, building codes, and EHS expectations.
• Coordinate commissioning and qualification activities, including system turnover, punch-list resolution, TAB, HEPA testing, room certification, environmental monitoring readiness, and other applicable CQV activities.
• Lead project meetings and provide clear reporting on schedule, cost, progress, risks, decisions, and upcoming activities.
• Proactively identify project risks and develop mitigation and recovery plans to minimize impacts to manufacturing operations, schedule, cost, and quality.
• Manage project closeout, including turnover packages, as-built documentation, training, final acceptance, and transition to Facilities/Operations.

Qualifications

Required: Bachelor's degree in Engineering, Construction Management, Architecture, or a related technical discipline; 10+ years of project management experience, with significant direct experience delivering cleanroom projects for pharmaceutical, biotechnology, or medical device facilities; demonstrated experience managing projects from design through construction and commissioning/qualification; strong knowledge of cleanroom HVAC, HEPA filtration, pressure relationships, controlled environments, utilities, and GMP facility requirements; and proven ability to manage multidisciplinary engineering and construction teams in an active manufacturing environment.

Preferred: Experience with ISO 5/7/8 and/or EU Grade A/B/C/D environments, cleanroom renovations within operating facilities, shutdown/tie-in planning, CQV and environmental monitoring coordination, and familiarity with applicable FDA, ISO, ISPE, and other life-sciences industry requirements. PMP and/or Professional Engineer (PE) certification is a plus.

Ideal Candidate

The successful candidate will be a hands-on Project Manager who understands both project execution and the technical complexities of cleanroom construction. The individual should be comfortable working directly with engineering, construction, Quality, Validation, Facilities, and Manufacturing teams and capable of driving projects through challenging field conditions while maintaining safety, GMP compliance, schedule predictability, cost control, and operational continuity.