GMP Project Engineer - Life Sciences Manufacturing

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

Benefits offered by this job

Medical, Dental, Vision

401(k) and matching

PTO & Holidays

Education Assistance

Pet Insurance

Fitness perks

Discounts

Job summary

PSC Biotech® Corporation is hiring an experienced Project Engineer to plan, design, execute, and deliver engineering projects in a regulated life sciences manufacturing environment. You will coordinate cross‑functional activities across facility, utility, equipment, lab, and infrastructure projects to align with GMP, quality, safety, and budgets.

The ideal candidate has hands‑on project experience in pharmaceutical/biotech environments, with ability to collaborate across Engineering,

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Biochemical Engineering, or another relevant engineering discipline.
• 5+ years experience within pharmaceutical, biotechnology, biologics, cell and gene therapy, medical device, or other FDA‑regulated manufacturing environments.
• Demonstrated experience managing or executing engineering projects in a GMP‑regulated facility.
• Working knowledge of engineering project lifecycle activities, including design, procurement, installation, commissioning, qualification, and turnover.
• Experience working with cross‑functional groups such as Manufacturing, Quality Assurance, Validation, Automation, Facilities, Maintenance, and EHS.
• Understanding of GMP documentation practices, change control, deviations, CAPA, and controlled engineering documentation.
• Experience coordinating vendors, contractors, and engineering firms.
• Strong project management, organization, communication, and problem‑solving skills.
• Ability to manage multiple priorities and work effectively in a fast‑paced manufacturing environment.
• Must be authorized to work in the U.S.
• No C2C at this time.

Responsibilities

• Lead and support engineering projects from concept and requirements definition through design, procurement, installation, commissioning, qualification, and project closeout.
• Develop project scopes, schedules, budgets, resource plans, and implementation strategies.
• Coordinate engineering activities involving manufacturing equipment, clean utilities, facilities, laboratories, automation, and supporting infrastructure.
• Develop and/or review engineering documentation, including URS, design drawings, equipment specs, engineering assessments, vendor docs, commissioning and qualification docs, turnover packages.
• Ensure projects are executed per GMP requirements, site quality systems, engineering standards, and EHS requirements.
• Partner with Quality and Validation to ensure commissioning, qualification, validation, and change control activities.
• Support a risk-based approach to project planning, equipment implementation, and qualification activities.
• Coordinate equipment installation, field activities, contractors, vendors, and service providers.
• Review vendor proposals, technical specs, drawings, submittals, and equipment documentation for compliance.
• Facilitate design reviews, project meetings, risk assessments, and technical troubleshooting.
• Monitor performance against scope, schedule, budget, quality, and safety; address risks.
• Manage engineering changes through change control and document control processes.
• Support equipment startup, commissioning, troubleshooting, and operational readiness.
• Coordinate turnover of completed systems to Manufacturing, Facilities, Maintenance, and other owners.
• Maintain clear project documentation and provide status updates to stakeholders.
• Identify opportunities to improve equipment reliability, efficiency, compliance, and execution.

Education

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Biochemical Engineering, or another relevant engineering discipline

Job description

PSC Biotech® Corporation is hiring an experienced Project Engineer to plan, design, execute, and deliver engineering projects in a regulated life sciences manufacturing environment. You will coordinate cross‑functional activities across facility, utility, equipment, lab, and infrastructure projects to align with GMP, quality, safety, and budgets.

The ideal candidate has hands‑on project experience in pharmaceutical/biotech environments, with ability to collaborate across Engineering,