JOB INFORMATION

Date Opened
08/18/2025
Job Type
Full time
Industry
Pharma/Biotech/Clinical Research
City
Minneapolis
State/Province
Minnesota
Country
United States

JOB DESCRIPTION

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 EXPERIENCE

With 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 make the decision to 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.

REQUIREMENTS

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 5–10 years of CQV experience in pharmaceutical and/or biotech environments.
• Minimum 3 years of hands-on experience with biologics API processing equipment and Cleaning Validation (CV), Clean-in-Place (CIP), and Steam-in-Place (SIP) systems.
• Experience in CQV protocol development and execution (IQ/OQ/PQ).
• Strong understanding of science- and risk-based CQV approaches, including ISPE Guides, Annex 15, and PIC/S.
• Excellent communication, organization, and project management skills.
• Detail-oriented with a strong commitment to quality and compliance.
• Willingness to travel or relocate for project assignments.

We are hiring experienced CQV Engineers to support commissioning, qualification, and validation (CQV) activities across pharmaceutical and biotech facilities. This role involves planning, executing, and documenting CQV deliverables for equipment, utilities, and systems, while ensuring compliance with regulatory standards and industry best practices.

• Develop and execute CQV protocols (IQ/OQ/PQ) for equipment, utilities, and systems.
• Prepare and maintain comprehensive documentation: validation plans, protocols, reports, and SOPs.
• Lead risk assessments and implement mitigation strategies for CQV activities.
• Troubleshoot and resolve issues related to equipment and process performance.
• Collaborate with cross-functional teams to ensure alignment on CQV deliverables and project timelines.
• Ensure compliance with global regulatory standards (FDA, EMA) and industry best practices (GMP, ISPE Guides, Annex 15, PIC/S).
• Support change management processes and field execution activities.
• Contribute to continuous improvement and knowledge sharing across validation teams.