Senior C&Q Engineer, Biopharma Systems | Onsite & Travel

Caiready; Limerick; Ibrido; EUR 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

CAI is seeking a Senior Commissioning & Qualification Engineer in Limerick to lead CQV activities across upstream and downstream bioprocessing on a high-profile biopharma project. You will ensure rigorous testing and compliance throughout the lifecycle of bioreactor systems, from development to commercial scale, while coordinating with cross-functional teams.

This site-based role requires strong CQV expertise, GMP/regulatory knowledge, and excellent documentation.

Competenze

• 5+ years of CQV/Validation experience in bioprocessing.
• Strong knowledge of GMP requirements and regulatory expectations.
• Hands-on upstream and downstream bioprocessing experience.
• Excellent documentation and stakeholder engagement skills.

Mansioni

• Lead full lifecycle CQV activities for upstream & downstream equipment.
• Commission and qualify bioreactor systems from development to scale-up.
• Support filtration, concentration, and purification systems qualification.
• Review IQ/OQ/PQ protocols and ensure GMP compliance.

Conoscenze

CQV

GMP

Bioreactors

Process equipment

Documentation

Formazione

Engineering or related field

Descrizione del lavoro

CAI is seeking a Senior Commissioning & Qualification Engineer in Limerick to lead CQV activities across upstream and downstream bioprocessing on a high-profile biopharma project. You will ensure rigorous testing and compliance throughout the lifecycle of bioreactor systems, from development to commercial scale, while coordinating with cross-functional teams.

This site-based role requires strong CQV expertise, GMP/regulatory knowledge, and excellent documentation.