GMP Project Engineer: Validation & Commissioning

Synerg; Marlboro (MA); On-site; USD 95,000 - 135,000; Full time

Job summary

Syner-G is seeking a Senior Project Engineer with 2–5 years of experience to support engineering, commissioning, validation, and operational readiness activities within GMP-regulated life sciences environments.

The ideal candidate will handle capital projects, facility and utility systems, engineering documentation, and cross-functional project execution, with prior validation experience preferred. Travel to client sites may be required up to 100% depending on project needs.

Qualifications

• 2–5 years in engineering, commissioning, validation, facilities, or operations within a GMP-regulated environment.
• Experience supporting capital projects in GMP manufacturing/facility environments.
• Hands-on startup/commissioning/validation of facility, utility, equipment, or process systems.
• Experience generating and managing engineering and validation documentation.
• Familiarity with cGMP documentation and validation lifecycle methodologies.
• Familiarity with BMS, PCS, CMMS, or similar technical systems.

Responsibilities

• Support capital projects from design through commissioning, qualification, validation, and startup.
• Startup and commissioning of building and utility systems such as HVAC, chilled water, water systems, electrical systems, fire protection, pH neutralization, and waste systems.
• Support validation and qualification activities, including protocol development, execution, discrepancy resolution, and final reporting.
• Generate and manage engineering and validation lifecycle documentation, including URS/FRS documents, FAT/SAT documentation, commissioning and qualification protocols, ETOPs, and P&IDs.
• Conduct drawings walkdowns and verify field installation of equipment, facilities, and utility systems.
• Develop and execute commissioning and qualification protocols and reports.
• Assist in troubleshooting, issue resolution, and risk assessments during commissioning, qualification, and startup activities.
• Coordinate with cross-functional teams including engineering, facilities, validation, operations, quality, and project management to support project deliverables.
• Assist in planning and scheduling project tasks, tracking progress, and ensuring timely completion of milestones.
• Communicate effectively with stakeholders to provide updates, elevate issues, and maintain alignment across project teams.
• Ensure all work complies with GMP, safety, quality, and regulatory requirements.

Skills

Project coordination

Documentation

Communication

Cross-functional collaboration

Technical writing

Education

Bachelor's Degree in Engineering

Tools

BMS

PCS

CMMS

KNEAT

Job description

Syner-G is seeking a Senior Project Engineer with 2–5 years of experience to support engineering, commissioning, validation, and operational readiness activities within GMP-regulated life sciences environments.

The ideal candidate will handle capital projects, facility and utility systems, engineering documentation, and cross-functional project execution, with prior validation experience preferred. Travel to client sites may be required up to 100% depending on project needs.