💼 About This Role

You'll create and maintain validation documentation for IT systems in a GMP-regulated environment. You'll partner with IT, Quality, Manufacturing, and Engineering teams to ensure compliance with regulations like 21 CFR Part 11. This role offers the chance to support system lifecycle activities at a trusted biotech company.

🎯 What You'll Do

• Create CSV plans, requirement specs, and test scripts.
• Support other IT teams executing CSV deliverables.
• Oversee routine compliance tasks like periodic review.
• Document impact assessments for change controls.

📋 Requirements

• Bachelor's degree in a technical discipline or associate degree plus 1-3 years CSV experience.
• Experience with 21 CFR Part 11 and GAMP compliance.
• Knowledge of Computer/Software validation (IQ/OQ/PQ).
• Proficiency in written and verbal communication.

✨ Nice to Have

• Experience in data governance and data integrity assessments.
• Understanding of deviation and change management for plant equipment software.
• Experience with lean principles and process metrics.

🎁 Benefits & Perks

• 💰 Target Bonus 8%
• 🏥 Health insurance (implied but not specified)
• 🗓️ Paid time off (implied but not specified)
• 🏢 On-site work in Syracuse, NY

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical Interview· 60 min