GMP Project Engineer: Capital Projects & Validation

BioSpace; New Marlborough (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Syner-G seeks a Sr. Project Engineer to support engineering, commissioning, validation, and operational readiness within GMP-regulated life sciences environments. 2–5 years in capital projects and cross-functional execution are preferred.

The role involves travel to client sites up to 100% and coordination across engineering, facilities, validation, and quality teams to ensure timely project delivery and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 2–5 years of experience in engineering, commissioning, validation, facilities, or operations within a GMP-regulated environment.
• Experience supporting capital projects and validation activities.

Responsibilities

• Support the execution of capital projects from design through commissioning, qualification, validation, and startup activities.
• Perform startup and commissioning of building and utility systems (HVAC, water, electrical, fire protection).
• Support validation and qualification activities, including protocol development, execution, and reporting.
• Generate and manage engineering and validation documentation (URS/FRS, FAT/SAT, P&IDs).
• Coordinate with cross-functional teams to support project deliverables.
• Communicate with stakeholders to maintain alignment and timelines.
• Ensure compliance with GMP, safety, and regulatory requirements.

Skills

Project management

Engineering fundamentals

Regulatory compliance

Technical writing

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Tools

BMS

PCS

CMMS

KNEAT

Job description

Syner-G seeks a Sr. Project Engineer to support engineering, commissioning, validation, and operational readiness within GMP-regulated life sciences environments. 2–5 years in capital projects and cross-functional execution are preferred.

The role involves travel to client sites up to 100% and coordination across engineering, facilities, validation, and quality teams to ensure timely project delivery and regulatory compliance.