Jobs and Careers
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Engineering Change Management Lead
PSC BiotechMinneapolis, United Statesfull_timeVerifiedPosted 3 Sept 2025
About the role
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.
Your Role
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.
Your Role
- Define and measure success metrics and monitor change progress
- Document control management
- Develop change management plans, define metrics, and identify risks
- Create and support Corrective Action Plans
- Assess change impact and communicate summary of impact
- Maintain Quality Management System (experience with TrackWise is preferred)
- Manage various facilities, packaging and process equipment, and aseptic operation projects
- Coordinate and execute all other projects (may include clean room/classified area modifications, equipment upgrades/modifications, equipment installation, etc.)
- Plan, coordinate, and monitor aseptic operations change control processes (i.e. aseptic operations, ISO 8 operations, hydration, filling, and component preparation)
Requirements
- Bachelor’s Degree in engineering or another relevant field
- Knowledge and experience
with ECM defined by ISPE
Baseline guide 5
- 2 plus years of experience in change control management and/or engineering
- Well-versed in planning, coordinating, and executing Change Control processes (specifically in packaging/processing and clean room area modifications)
- Familiarity with TrackWise
- Advanced experience with Vial Packaging Lines, Solid Dose Lines, Aseptic Fill Lines, Lyos (freeze dryers), Parts Washers, and Autoclaves
- Proficient in ISO 8 and ISO 5
- Exceptional communication skills (verbal and written)
- Strong organizational and problem-solving skills
- Excellent math and analytical abilities
Benefits
Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
- Financial Perks and Discounts<
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