CSV Engineer

We are seeking a CSV Engineer to support computerized system validation activities within a regulated manufacturing environment. This individual will work closely with cross-functional teams to ensure automation and manufacturing systems are implemented, tested, and maintained in compliance with regulatory standards. The role will play a key part in supporting system lifecycle activities, with a strong emphasis on documentation, compliance, and data integrity.

• Support the validation lifecycle for computerized systems, including development, review, and execution of validation deliverables.
• Partner with Engineering, Quality, IT, and external vendors to ensure systems are implemented and maintained in alignment with regulatory and internal standards
• Assist in the configuration, testing, and troubleshooting of automation and manufacturing-related software applications.
• Evaluate system changes and support change control activities, including impact assessments and associated documentation updates.
• Ensure systems meet data integrity and electronic records/electronic signature requirements (e.g., 21 CFR Part 11).
• Support integration and data flow between manufacturing systems (e.g., equipment automation, MES/OMS platforms) to ensure reliable and accurate system performance.
• Review and approve technical and validation documentation to ensure completeness, accuracy, and compliance with cGMP requirements.

Do you have experience in Validation design?, * Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related discipline.

• 3-6 years of experience in computerized system validation, automation systems, or manufacturing software support within a regulated industry (pharma, biotech, or medical device).
• Working knowledge of cGMP requirements and validation frameworks (e.g., GAMP 5).
• Familiarity with manufacturing systems such as automation platforms, control systems, and/or MES/OMS applications.
• Experience with validation documentation, including protocol development, execution, and traceability.
• Strong technical troubleshooting and analytical skills.
• Excellent written and verbal communication skills, with the ability to collaborate across functional teams.
• Must be authorized to work in the U.S.
• No C2C at this time.

Pulled from the full job description

• Pet insurance
• 401(k)
• Health insurance
• 401(k) matching
• Paid time off
• Vision insurance
• Dental insurance, 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
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

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.