💼 About This Role

You'll lead CQV activities for GMP equipment at a client site in Raleigh, NC. You'll ensure regulatory compliance and seamless integration with client engineering and automation teams. This role offers independence and technical leadership within a supportive ESOP company.

🎯 What You'll Do

• Execute CQV for autoclaves, CIP/SIP systems, bioreactors, and incubators.
• Develop and review validation documentation including URS, DQ, IQ, OQ, PQ.
• Perform risk assessments and impact analyses for validation strategy.
• Coordinate with client engineering, automation, and quality teams.

📋 Requirements

• Bachelor's degree in engineering or life sciences.
• 3+ years of CQV experience in a GMP-regulated environment.
• Strong understanding of validation lifecycle and regulatory expectations.
• Ability to work independently and manage multiple priorities.

✨ Nice to Have

• Experience with automated systems and controls integration.

🎁 Benefits & Perks

• 🏥 Premium medical coverage
• 💰 401(k) with company match
• 📚 Tuition reimbursement
• 🏆 Unique performance incentives
• 📈 Employee Stock Ownership Plan (ESOP)

🚩 Heads Up

• Requires onsite presence in Raleigh, NC but mentions NEPA in description.
• Role expects both independent work and leadership without clear title or authority.