Lead C&Q Engineer - Biopharma GMP & CQV Expert

CAI; Limerick; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

CAI is looking for a Lead C&Q Engineer in Limerick to oversee C&Q activities on a major biopharma project. This role requires an experienced professional with over 10 years in CQV/Validation, possessing strong knowledge of GMP and regulatory requirements. The key responsibilities include leading C&Q activities, ensuring compliance, and mentoring junior engineers. Candidates should hold an engineering degree and be eligible to work in Ireland, with a commitment of 40+ hours per week.

Qualifikationen

• 10+ years’ experience in Commissioning & Qualification / CQV / Validation.
• Strong working knowledge of GMP requirements and FDA/EMA regulations.
• Extensive experience working with bioreactors.

Aufgaben

• Lead and oversee C&Q activities across upstream and downstream process systems.
• Act as the primary escalation point for technical issues.
• Conduct system walkdowns and readiness reviews.

Kenntnisse

GMP requirements and FDA/EMA regulations

Hands-on upstream and downstream bioprocess knowledge

Excellent documentation, communication, and stakeholder engagement skills

Ausbildung

Degree in Engineering, Biotechnology, or Pharmaceutical Sciences

Tools

Bioreactors

Filtration and concentration systems

Jobbeschreibung

CAI is looking for a Lead C&Q Engineer in Limerick to oversee C&Q activities on a major biopharma project. This role requires an experienced professional with over 10 years in CQV/Validation, possessing strong knowledge of GMP and regulatory requirements. The key responsibilities include leading C&Q activities, ensuring compliance, and mentoring junior engineers. Candidates should hold an engineering degree and be eligible to work in Ireland, with a commitment of 40+ hours per week.