🛠 Tech Stack

💼 About This Role

You'll perform equipment qualifications including IQ, OQ, and PQ in a GMP-regulated biopharma environment. Your work will directly support validation of automated production systems for life-enhancing therapies.

🎯 What You'll Do

• Perform equipment qualifications including Commissioning, IQ, OQ, and PQ
• Provide hands-on engineering support during equipment startup
• Write, review, approve, and execute validation protocols and reports
• Lead and mentor a small team of CQV engineers

📋 Requirements

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or related life science field
• 5-7 years of experience in biotech, pharmaceutical, or medical device industries
• Strong understanding of GMP, FDA regulations, FMEA, and risk analysis
• Proficient in AutoCAD and SolidWorks

✨ Nice to Have

• Experience with high-speed fill-finish lines
• Familiarity with PLCs, HMIs, and automated manufacturing systems

🎁 Benefits & Perks

• 🏆 Best Places to Work award winner for three consecutive years
• 📈 Career growth and development opportunities
• 💰 Financial rewards
• 🏖️ Remote work/flexibility

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter call· 30 min
2. 2Technical interview· 60 min
3. 3On-site interview· 90 min