Senior Project Engineer (GMP) – Capital Projects

Socket.dev; Marlborough (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

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

You will coordinate capital projects from design through startup, validate building and utility systems, and manage comprehensive documentation across URS/FRS, FAT/SAT, and P&IDs, ensuring GMP and safety standards are met across site work and client interactions.

Qualifications

• 2–5 years of experience in engineering, commissioning, validation, facilities, or operations within a GMP-regulated pharmaceutical, biotechnology, or industrial environment.
• Experience supporting capital projects within GMP-regulated manufacturing or facility environments.
• Prior validation experience supporting capital projects is preferred.
• Hands-on experience with startup, commissioning, qualification, or validation of facility, utility, equipment, or process systems.
• Experience generating and managing engineering and validation documentation.
• Experience with drawing walkdowns, field verification, and construction turnover activities.
• Familiarity with cGMP documentation practices and validation lifecycle methodologies.
• Familiarity with BMS, PCS, CMMS, or similar technical systems.
• Experience with KNEAT or digital validation documentation platforms is a plus.

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 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 impact assessments, URS/FRS documents, FAT/SAT documentation, commissioning protocols, qualification protocols, ETOPs, and P&IDs.
• Conduct drawing walkdowns and verify field installation of equipment, facilities, and utility systems.
• Develop and execute commissioning and qualification protocols and reports.
• Support 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, escalation issues, and maintain alignment across project teams.
• Ensure all work complies with GMP, safety, quality, and regulatory requirements.

Skills

Strong communication

Interpersonal skills

Documentation

Organizational skills

Technical writing

Independent & collaborative work

Problem solving

Education

Bachelor's Degree in Engineering

Tools

BMS

PCS

CMMS

KNEAT

Job description

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

You will coordinate capital projects from design through startup, validate building and utility systems, and manage comprehensive documentation across URS/FRS, FAT/SAT, and P&IDs, ensuring GMP and safety standards are met across site work and client interactions.