Job Description
Your Role

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.

Requirements

• 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.

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
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

Equal Opportunity Employment Statement

PSC Biotech 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.

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