🛠 Tech Stack

💼 About This Role

You'll lead commissioning and qualification activities for a large-scale biopharma project, overseeing upstream and downstream systems. Your core impact involves ensuring GMP compliance and inspection readiness while coordinating with cross-functional teams. This role stands out due to its high-profile nature and leadership of a complex bioreactor programme.

🎯 What You'll Do

• Oversee C&Q lifecycle for upstream and downstream process systems.
• Act as escalation point for technical issues and risk mitigation.
• Conduct system walkdowns and readiness reviews.
• Develop and manage C&Q resource plan aligned with milestones.
• Track and report project progress with weekly updates.

📋 Requirements

• 10+ years experience in Commissioning & Qualification / CQV / Validation.
• Strong working knowledge of GMP requirements, FDA and EMA regulations.
• Strong hands-on upstream and downstream bioprocess knowledge.
• Extensive experience with bioreactors, filtration and concentration systems.

✨ Nice to Have

• Experience with Emerson/DeltaV automation systems.
• Mentoring junior engineers.
• Experience with regulatory inspections.

🎁 Benefits & Perks

• 🏖️ Competitive PTO
• 🏥 Health insurance
• 📈 Professional development opportunities
• 🤝 Collaborative team environment
• 📍 Site-based role in Limerick

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Phone Screen· 30 min
2. 2Technical Interview with Hiring Manager· 60 min
3. 3Panel Interview· 60 min