Validation Engineer (Biotech)

TL;DR

Validation Engineer (Biotech): Supporting system validation activities within regulated manufacturing environments with an accent on automation software and manufacturing equipment compliance. Focus on ensuring systems meet data integrity and regulatory standards like 21 CFR Part 11 and GAMP 5.

Location: Must be authorized to work in the U.S. (Columbus, United States)

Company

hirify.global provides essential services to the life sciences industry to ensure health care products are developed, manufactured, and distributed in compliance with regulatory standards.

What you will do

• Support the validation lifecycle for automation and computerized systems, including development and execution of deliverables.
• Partner with Engineering, Quality, and IT teams to ensure systems align with regulatory and internal standards.
• Assist in the configuration, testing, and troubleshooting of manufacturing-related software applications.
• Evaluate system changes and support change control activities, including impact assessments.
• Ensure systems meet data integrity and electronic records/signature requirements.
• Review and approve technical documentation to ensure compliance with cGMP requirements.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline.
• Minimum of 3 years of experience in computerized system validation within regulated life science industries.
• Strong knowledge of cGMP requirements, GAMP 5, and Part 11 Compliance.
• Experience with validation documentation, protocol development, and traceability.
• Must be authorized to work in the U.S.
• No C2C at this time.

Culture & Benefits

• Medical, Dental, and Vision insurance with 100% employer-paid premiums for employees.
• 401(k) plan with company matching.
• Comprehensive insurance options including life and disability.
• Paid Time Off, sick time, and paid holidays.
• Education assistance and pet insurance.
• Discounted rates at Anytime Fitness.