GMP Facilities Project Engineer | CQV & Commissioning

DPS Group Global; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical

Dental

Vision

EAP

401K

STD

LTD

AD&D

Life insurance

Paid parental leave

Reward & recognition program

Wellbeing benefits

Adoption assistance

Tuition reimbursement

Nine paid holidays

15 days PTO

Job summary

Arcadis is seeking a Facilities Project Engineer to support manufacturing equipment, utilities, and facility systems in a GMP-regulated pharmaceutical environment. You will review engineering design packages, oversee change controls, and participate in commissioning, qualification, and validation activities to ensure compliant, reliable operations.

The role requires at least four years of relevant experience in regulated pharma settings and a degree in Chemical/Mechanical/Electrical Engineering.

Qualifications

• Minimum of four years of relevant experience performing site, facilities, plant, or process engineering activities in a GMP-regulated pharmaceutical manufacturing environment.
• Bachelor’s degree in Chemical, Mechanical, Electrical Engineering, or another related engineering discipline.
• Experience in designing, implementing, starting up, and qualifying GMP manufacturing, utility, and facility equipment.
• Ability to read and interpret engineering drawings, specifications, manuals, and vendor documentation.
• Strong communication, technical writing, and cross-functional collaboration skills for GMP documentation.
• Familiarity with FDA and EU regulatory requirements (21 CFR, Annex 1) for pharmaceutical facilities and equipment.

Responsibilities

• Review design packages and vendor submittals for compliance with standards and regulatory requirements.
• Review and develop technical specifications for equipment and facility systems.
• Provide engineering oversight through design, fabrication, installation, and startup; coordinate with architects, vendors, and internal stakeholders.
• Own change controls per SOPs and regulatory requirements.
• Review drawings, P&IDs, submittals, SOPs, and literature; prepare as-built documentation and updates.
• Support commissioning and qualification activities (FAT, SAT, IQ, OQ) with validation teams.
• Support CAPA, deviation resolution, and inspection readiness for audits.
• Troubleshoot on-floor equipment and systems to restore operations.
• Assist with system transitions during construction, shutdowns, and startup to maintain business continuity.
• Participate in meetings and provide timely updates and service reporting.

Skills

Project management

GMP compliance

Change control

P&ID review

Cross-functional collaboration

Education

Bachelor's degree in Chemical/Mechanical/Electrical Engineering

Tools

CMMS

BMS

EMS

SCADA

CAD

Job description

Arcadis is seeking a Facilities Project Engineer to support manufacturing equipment, utilities, and facility systems in a GMP-regulated pharmaceutical environment. You will review engineering design packages, oversee change controls, and participate in commissioning, qualification, and validation activities to ensure compliant, reliable operations.

The role requires at least four years of relevant experience in regulated pharma settings and a degree in Chemical/Mechanical/Electrical Engineering.