GMP Project Engineer – Biotech/Pharma

PSC Biotech; Boulder (CO); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical/Dental/Vision premiums covered

401(k) with matching

Paid time off

Education assistance

Pet Insurance

Fitness perks

Discounts

Job summary

PSC Biotech seeks an experienced Project Engineer to support planning, design, execution, and delivery of engineering projects in a regulated life sciences manufacturing environment. You will coordinate cross-functional activities across facilities, manufacturing, quality, and validation, ensuring GMP alignment and adherence to budgets and schedules.

The ideal candidate has hands-on project experience in pharmaceutical/biotech settings and will work with Engineering, Manufacturing, Quality,

Qualifications

• Bachelor's degree in Chemical, Mechanical, Electrical, Biomedical, Biochemical, or related engineering discipline.
• 5+ years in pharmaceutical/biotech/regulated manufacturing environments.
• Demonstrated experience managing or executing engineering projects in GMP facilities.
• Knowledge of GMP documentation practices, change control, deviations, and CAPA.
• Experience coordinating vendors, contractors, and engineering firms.
• Must be authorized to work in the U.S.; No C2C.

Responsibilities

• Lead and manage engineering projects from concept through design, procurement, installation, commissioning, qualification, and closeout.
• Develop scopes, schedules, budgets, and resource plans for projects.
• Coordinate activities involving equipment, utilities, facilities, automation, and infrastructure.
• Prepare URS, design specs, drawings, equipment specs, and assessments.
• Ensure projects comply with GMP, quality systems, and EHS requirements.
• Collaborate with Quality and Validation on commissioning, qualification, and change control.
• Assess risks and drive project planning and problem-solving to keep delivery on track.
• Coordinate turnover to Manufacturing, Facilities, and maintenance teams.

Skills

Project management

GMP compliance

Cross-functional collaboration

Communication

Problem-solving

Education

Bachelor's degree in engineering

Job description

PSC Biotech seeks an experienced Project Engineer to support planning, design, execution, and delivery of engineering projects in a regulated life sciences manufacturing environment. You will coordinate cross-functional activities across facilities, manufacturing, quality, and validation, ensuring GMP alignment and adherence to budgets and schedules.

The ideal candidate has hands-on project experience in pharmaceutical/biotech settings and will work with Engineering, Manufacturing, Quality,