CSV Automation Engineer

PSC Biotech

  • Minneapolis, MN
  • Permanent
  • Full-time
  • 17 days ago
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 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 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 RoleWe are hiring experienced CQV/CSV Automation Engineers to lead commissioning, qualification, and validation activities for automated systems and process equipment in pharmaceutical and biotech environments. This role is critical in ensuring that control systems and automation components meet regulatory, functional, and performance requirements throughout the project lifecycle.
  • Develop and execute CQV/CSV protocols (IQ/OQ/PQ) for automated systems and control equipment.
  • Support commissioning and qualification of PLC-based control systems, instrumentation, and automation infrastructure.
  • Troubleshoot and resolve issues related to automation hardware, software, and system integration.
  • Collaborate with engineering, operations, and quality teams to ensure alignment on automation validation deliverables.
  • Prepare and maintain validation documentation, including protocols, reports, and change records.
  • Ensure compliance with applicable regulatory standards (FDA, EMA) and industry guidance (GMP, ISPE, Annex 15, PIC/S).
  • Participate in risk assessments and implement mitigation strategies for automation-related CQV activities.
  • Support field execution, FAT/SAT testing, and change management processes.
Requirements
  • Bachelor’s degree in Engineering, Automation, or a related technical field.
  • 5–10 years of CQV/CSV experience in pharmaceutical or biotech industries, with a focus on automation systems.
  • Hands-on experience with PLCs (Programmable Logic Controllers) including configuration, programming, and troubleshooting.
  • Experience working with Ethernet communication cards and networked control systems.
  • Proficiency with VFDs (Variable Frequency Drives) including setup, tuning, and integration with control systems.
  • Experience with instrument air systems, including validation of pneumatic controls and instrumentation.
  • Strong understanding of automation lifecycle documentation and validation principles.
  • Familiarity with digital validation platforms such as Kneat or Veeva is a plus.
  • Excellent problem-solving, communication, and project coordination skills.
  • Excellent attention to detail with commitment to quality and compliance.
  • Willingness to travel or relocate for project assignments.
BenefitsOffering 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
Equal Opportunity Employment StatementPSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.#LI-JD1

PSC Biotech