Project Engineer

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.

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.

• Lead and coordinate engineers and contractors throughout project execution.
  
• Coordinate commissioning and startup of new equipment, utilities, and cleanroom systems.
  
• Develop and approve IQ/OQ/PQ protocols for newly installed systems and equipment.
  
• Prepare, review, and maintain documentation, including validation protocols, plans, reports, and SOPs.
  
• Ensure timely execution of PPQ testing and validation deliverables.
  
• Coordinate with vendors and contractors to support hand-offs and system turnover.
  
• Ensure compliance with regulatory requirements (FDA, EMA) and industry standards (GMP, GAMP).
  
• Provide technical oversight during validation execution and qualification activities.
  
• Additional responsibilities as required.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field.
  
• 4-5 years of project experience in pharmaceutical and/or biotech industries.
  
• Proven experience coordinating CQV activities during new facility build outs, including equipment installation and startup.
  
• Familiarity with project execution and project management tools (MS Project, Smartsheet).
  
• Understanding of regulatory requirements and industry standards.
  
• Knowledge of validation lifecycle.
  
• Strong technical writing skills and experience with validation documentation (protocols, reports, procedures).
  
• Effective communication and interpersonal skills.
  
• Organized, proactive, and detail-oriented with a commitment to quality and compliance.
  
• Must be authorized to work in the U.S
  
• No C2C at this time

Benefits