Validation Engineer

biotech; Columbus (OH); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, and Vision benefits

401(k) matching

Education Assistance

Job summary

PSC Biotech in Columbus, Ohio, seeks a Validation Engineer to oversee system validation activities in regulated manufacturing. Responsibilities include supporting validation lifecycles, collaborating with cross-functional teams, and ensuring compliance with regulatory standards.

The ideal candidate should have a Bachelor's degree, at least 3 years of experience in computerized system validation, and familiarity with cGMP requirements. The offer includes comprehensive health benefits and a supportive work environment.

Qualifications

• Minimum of 3 years of experience in computerized system validation.
• Strong knowledge of cGMP requirements and validation frameworks.
• Experience with validation documentation including protocol development.

Responsibilities

• Support the validation lifecycle for automation and computerized systems.
• Partner with Engineering, Quality, and IT to ensure regulatory compliance.
• Assist in configuration, testing, and troubleshooting of software applications.

Skills

Computerized system validation

Technical troubleshooting

Cognitive skills

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or related discipline

Job description

The Validation Engineer supports system validation activities within regulated manufacturing environments. The role works closely with cross‑functional teams to ensure automation software and manufacturing equipment/systems are implemented, tested, validated, and maintained in compliance with regulatory standards.

Responsibilities

• Support the validation lifecycle for automation and 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.
• Additional related responsibilities as required.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related discipline.
• Minimum of 3 years of experience in computerized system validation, automation software, and manufacturing systems within regulated life science industries (pharma, biotech).
• Well‑versed in manufacturing systems, including automation platforms, control systems, and MES/OMS applications.
• Strong knowledge of cGMP requirements and validation frameworks (Part 11 Compliance, GAMP 5).
• 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

• Medical, Dental, and Vision – PSC pays 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• 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 is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, 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.