Senior Project Engineer — GMP Life Sciences & Validation

Initial Therapeutics, Inc.; New Marlborough (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Syner-G is seeking a Sr. Project Engineer to support engineering, commissioning, validation, and operational readiness within GMP-regulated life sciences environments. Travel to client sites may be required up to 100% depending on project needs.

The ideal candidate has 2–5 years of hands-on experience with capital projects, facility systems, and cross‑functional project execution, with a strong foundation in documentation and regulatory compliance.

Qualifications

• Bachelor's Degree in Engineering or related field.
• 2–5 years in GMP-regulated pharma/biotech environments.
• Experience supporting capital projects.
• Startup, commissioning, qualification, or validation experience.

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, 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 documentation, including 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.
• Utilize systems such as BMS, PCS, and CMMS; experience with KNEAT is a plus.
• 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

GMP experience

Capital projects

Cross-functional teams

Validation documentation

Education

Bachelor's Degree in Engineering

Tools

BMS

PCS

CMMS

KNEAT

Job description

Syner-G is seeking a Sr. Project Engineer to support engineering, commissioning, validation, and operational readiness within GMP-regulated life sciences environments. Travel to client sites may be required up to 100% depending on project needs.

The ideal candidate has 2–5 years of hands-on experience with capital projects, facility systems, and cross‑functional project execution, with a strong foundation in documentation and regulatory compliance.