Project Engineer, Quality Engineering
Listed on 2026-10-05
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Engineering
Quality Engineering, Process Engineer
Boulder, United States | Posted on 10/01/2026
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The ExperienceWith operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you decide join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech, it’s about more than just a job—it’s about your career and your future.
Your RoleWe are hiring an experienced Project Engineer who will support the planning, design, execution, and delivery of engineering projects within a regulated life sciences manufacturing environment. The Project Engineer will coordinate cross-functional activities associated with facility, utility, manufacturing equipment, laboratory, and infrastructure projects while ensuring alignment with GMP requirements, quality standards, safety expectations, project schedules, and approved budgets.
The ideal candidate will bring hands‑on engineering project experience within the pharmaceutical, biotechnology, biologics, or other regulated life sciences industry and be comfortable working across Engineering, Manufacturing, Quality, Validation, Automation, Facilities, EHS, and external vendors.
- 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:
- User Requirements Specifications (URS)
- Design specifications and drawings
- Equipment specifications
- Engineering assessments
- Commissioning and qualification documentation
- Turnover and closeout packages
- Ensure engineering projects are executed in accordance with applicable GMP requirements, site quality systems, engineering standards, and EHS requirements.
- Partner with Quality and Validation teams to ensure appropriate commissioning, qualification, validation, and change control activities are incorporated into project execution.
- Support a risk‑based approach to project planning, equipment implementation, and qualification activities.
- Coordinate equipment installation, field activities, construction contractors, equipment vendors, and engineering service providers.
- Review vendor proposals, technical specifications, drawings, submittals, and equipment documentation for compliance with project requirements.
- Facilitate design reviews, project meetings, risk assessments, and technical troubleshooting sessions.
- Monitor project performance against scope, schedule, budget, quality, and safety objectives…
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