Senior Project Engineer – Life Sciences GMP Projects

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

Benefits offered by this job

Medical, Dental, Vision premiums paid

401(k) with matching

Paid time off and holidays

Education assistance

Job summary

PSC Biotech is hiring a 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 facility, utility, equipment, laboratory and infrastructure projects, ensuring GMP compliance, quality, safety and budgets.

The ideal candidate has hands-on project experience in pharmaceutical/biotech/biologics or other FDA-regulated settings and will collaborate with

Qualifications

• Bachelor's degree in an engineering discipline (Chemical/Mechanical/Electrical/Biomedical or similar).
• 5+ years of experience in pharmaceutical/biotech/regulated environments.
• Experience managing/executing GMP-regulated projects.
• Knowledge of GMP documentation, change control, CAPA and engineering docs.
• Experience coordinating vendors, contractors and engineering firms.

Responsibilities

• Lead and support engineering projects from concept through closeout.
• Develop scopes, schedules, budgets, and resource plans.
• Coordinate activities across manufacturing, facilities, automation and QA.
• Review design specs, equipment docs, URS and qualification docs.
• Ensure projects meet GMP, quality, safety and budget requirements.
• Facilitate design reviews and risk assessments.
• Support commissioning, qualification and change control activities.

Skills

Cross-functional collaboration

Project management

GMP knowledge

Engineering documentation

Change control

Risk assessment

Vendor coordination

Communication

Problem-solving

Education

Bachelors in Chemical/Mechanical/Electrical/Biomedical Eng

5+ years in FDA-regulated manufacturing

Job description

PSC Biotech is hiring a 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 facility, utility, equipment, laboratory and infrastructure projects, ensuring GMP compliance, quality, safety and budgets.

The ideal candidate has hands-on project experience in pharmaceutical/biotech/biologics or other FDA-regulated settings and will collaborate with