On-Site Sterile Equipment Validation Engineer

Careerwise Recruitment; Galway; On-site; EUR 60,000 - 100,000; Full time

Job summary

CareerWise Recruitment is seeking a Technical Services Engineer for a Galway-based client. The role focuses on qualifying pharmaceutical equipment, utilities, and systems used in sterile injectable manufacturing, ensuring validation and regulatory compliance.

You will develop and execute IQ/OQ/PQ protocols, support regulatory inspections, and collaborate with cross-functional teams to maintain validated state and drive continuous improvement in qualification processes.

Qualifications

• Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field) or Life Sciences.
• 5–7 years of experience in validation, equipment qualification, or technical services within sterile injectables manufacturing.
• Familiarity with endotoxin spiking procedure and depyrogenation tunnel qualification.
• Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
• Familiarity with Process Analytical Technology (PAT) and digital validation tools.
• Technical skills: IQ/OQ/PQ for aseptic processing equipment and utilities.
• Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.
• Experience with validation lifecycle approach (URS, FAT/SAT, PQ).
• Knowledge of data integrity (ALCOA+ principles) and computerized system validation (CSV).
• Practical familiarity with environmental monitoring systems and cleanroom qualification.

Responsibilities

• Develop, execute, and review IQ, OQ, and PQ protocols for sterile manufacturing equipment.
• Ensure compliance with cGMP, FDA, EMA, and Annex 1 requirements for validation activities.
• Perform risk assessments (e.g., FMEA) to determine validation strategies and critical parameters.
• Maintain the validated state of manufacturing equipment, clean utilities, and process support systems.
• Qualify and validate aseptic filling lines, Lyophilisers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
• Support clean utilities qualification (WFI, clean steam, compressed air, HVAC).
• Ensure validation of automation and control systems (SCADA, PLC, MES).
• Author and review validation documentation (VMPs, protocols, reports).
• Support audits and regulatory inspections with validation data and justifications.
• Assess impact of equipment modifications and process changes on validated state.

Skills

IQ/OQ/PQ

cGMP knowledge

Risk assessment

Regulatory compliance

Lean Six Sigma

CSV knowledge

Education

Engineering or Life Sciences degree

Tools

SCADA

PLC

MES

VMP

Job description

CareerWise Recruitment is seeking a Technical Services Engineer for a Galway-based client. The role focuses on qualifying pharmaceutical equipment, utilities, and systems used in sterile injectable manufacturing, ensuring validation and regulatory compliance.

You will develop and execute IQ/OQ/PQ protocols, support regulatory inspections, and collaborate with cross-functional teams to maintain validated state and drive continuous improvement in qualification processes.