CQV Requalification Engineer - Sterile Equipment Specialist

EFOR; Waterford; On-site; EUR 60,000 - 90,000; Full time

Job summary

EFOR Group, a Life Sciences consulting partner, is seeking an Equipment Requalification Engineer for Waterford, Ireland. This onsite, hands-on role focuses on assessing, writing, executing and reporting requalification protocols for sterile manufacturing equipment, alongside QA and equipment owners.

You will apply a risk-based FMEA approach, review status and records, and help implement the new requalification process across sites.

Qualifications

• Hands-on experience writing and executing qualification and requalification protocols (IQ/OQ/PQ)
• Periodic reviews of requalification records
• Risk-based approach to set scope and frequency (FMEA)

Responsibilities

• Assess equipment requalification practices vs global guidance
• Review requalification status, frequencies and records, identify gaps
• Apply risk-based approach to set scope and frequency for each system
• Write, execute and report requalification protocols with Engineering, QA and owners
• Work on sterile manufacturing equipment (autoclaves, depyrogenation, washers, isolators/RABS, filling, temperature-controlled units, CIP/SIP)
• Help implement new requalification process and hand over to routine operations

Skills

CQV/Validation experience

FMEA risk assessment

Autonomous/execution-focused

Documentation discipline

QA collaboration

Education

Engineering degree + CQV experience

Tools

Kneat

ValGenesis

Temperature mapping

Job description

EFOR Group, a Life Sciences consulting partner, is seeking an Equipment Requalification Engineer for Waterford, Ireland. This onsite, hands-on role focuses on assessing, writing, executing and reporting requalification protocols for sterile manufacturing equipment, alongside QA and equipment owners.

You will apply a risk-based FMEA approach, review status and records, and help implement the new requalification process across sites.