Computer Systems Validation Specialist III (Biotech)

Location: On-site in Portsmouth, New Hampshire, United States. Relocation assistance is available for eligible candidates and their families.

Company

hirify.global operates more than 30 sites across five continents and manufactures medicines and life-science products.

What you will do

• Lead CSV activities and projects for new and changing computer systems.
• Perform QMS processes, including change control, deviations, and CAPAs.
• Conduct gap assessments, define remediation plans, and initiate quality records.
• Author, review, and approve end-to-end computer system validation lifecycle deliverables.
• Schedule qualification activities and personnel to meet manufacturing, engineering, quality, and business objectives.
• Maintain SOPs, review engineering documentation, and provide CSV subject-matter expertise during customer audits and inspections.

Requirements

• Bachelor’s degree in computer science, engineering, or a related field.
• At least 3 years of computer systems validation experience.
• At least 3 years of experience working in a cGMP facility.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines, especially for analytical computerized systems.
• Background in biotechnology, pharmaceuticals, or medical devices.
• Ability to work independently and on-site in Portsmouth, New Hampshire.

Culture & Benefits

• Collaborative and inclusive work environment.
• Career growth, development, mentoring, and supportive leadership.
• Access to advanced technologies and tools.
• Competitive compensation and benefits package.
• 401(k) matching plan.
• Commitment to ethical and sustainable practices.