Sr. Project Engineer

About the role

We are seeking a Sr. Project Engineer with 2–5 years of experience supporting engineering, commissioning, validation, and operational readiness activities within GMP-regulated life sciences environments. The ideal candidate will have hands-on experience supporting capital projects, facility and utility systems, engineering documentation, and cross-functional project execution. Prior validation experience supporting capital projects is preferred. This role is suited for an engineer who has developed a solid technical foundation and is ready to take on increased responsibility in coordinating and executing engineering, validation, and commissioning activities throughout the project lifecycle.

Work location: Travel to client sites may be required up to 100%, depending on project needs and client expectations.

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.
• 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, escalate issues, and maintain alignment across project teams.
• Ensure all work complies with GMP, safety, quality, and regulatory requirements.

Qualifications

Education: Bachelor's Degree in Engineering or a related technical field.

Technical Experience:

• 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.

Skills

• Strong understanding of facility, utility, equipment, and process systems within regulated manufacturing environments.
• Working knowledge of commissioning, qualification, validation, and capital project execution methodologies.
• Excellent documentation, organizational, and technical writing skills.
• Ability to manage multiple tasks, priorities, and deadlines in a fast-paced project environment.
• Strong communication and interpersonal skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Ability to work independently and collaboratively across multidisciplinary teams.