Morgan McKinley·12 days ago
12 days ago
Equipment Validation Engineer
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What you'll do
- Develop, execute, and review IQ/OQ/PQ protocols, URS, and RTM for sterile manufacturing equipment, clean utilities (WFI, clean steam, HVAC, compressed air), and automated control systems (PLC, SCADA, MES).
- Deliver hands-on qualification for aseptic filling lines, autoclaves, depyrogenation tunnels, and isolators/RABS.
- Manage load preparation, thermocouple placement, biological indicators, and autoclave execution.
- Author VMPs, protocols, and reports aligned with cGMP, FDA, EMA, and Annex 1 standards.
- Provide technical validation data during regulatory inspections.
- Conduct FMEA risk assessments, investigate deviations/CAPAs, and manage change controls to protect the validated state.
- Work closely with Engineering, Quality, and Operations to streamline qualification cycle times using Lean/Six Sigma principles.
What they're looking for
- Bachelor's or Master's degree (Level 8+) in Engineering, Science, or a related technical discipline.
- 4-5 years in validation/equipment qualification within a sterile injectables environment.
- Hands-on knowledge of IQ/OQ/PQ, full lifecycle validation (FAT/SAT to PQ), CSV, data integrity (ALCOA+), cleanroom qualification, and depyrogenation/autoclave operations.
- Deep understanding of Annex 1, ICH Q9/Q10, and FDA Process Validation guidance.
- Strong analytical problem-solving, project management, and cross-functional leadership skills.
Nice to have
- Hands-on experience with endotoxin spiking procedures for depyrogenation tunnel qualification.
- Lean Six Sigma or CQE certification.
- Exposure to Process Analytical Technology (PAT) or digital validation tools.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Joining the Technical Services team, the Equipment Validation Engineer will drive the qualification and validation of equipment, clean utilities, and automated systems used in sterile injectable manufacturing. This role ensures all assets are fully compliant, maintained in a validated state, and ready for operational use.
Key Responsibilities
- Validation & Qualification: Develop, execute, and review IQ/OQ/PQ protocols, URS, and RTM for sterile manufacturing equipment, clean utilities (WFI, clean steam, HVAC, compressed air), and automated control systems (PLC, SCADA, MES).
- Sterile Processing Support: Deliver hands-on qualification for aseptic filling lines, autoclaves, depyrogenation tunnels, and isolators/RABS. Manage load preparation, thermocouple placement, biological indicators, and autoclave execution.
- Compliance & Audits: Author VMPs, protocols, and reports aligned with cGMP, FDA, EMA, and Annex 1 standards. Provide technical validation data during regulatory inspections.
- Risk & Change Management: Conduct FMEA risk assessments, investigate deviations/CAPAs, and manage change controls to protect the validated state.
- Cross-Functional Lead: Work closely with Engineering, Quality, and Operations to streamline qualification cycle times using Lean/Six Sigma principles.
Required Experience & Skills
- Education: Bachelor's or Master's degree (Level 8+) in Engineering, Science, or a related technical discipline.
- Experience: 4-5 years in validation/equipment qualification within a sterile injectables environment.
- Technical Expertise: Hands-on knowledge of IQ/OQ/PQ, full lifecycle validation (FAT/SAT to PQ), CSV, data integrity (ALCOA+), cleanroom qualification, and depyrogenation/autoclave operations.
- Regulatory Knowledge: Deep understanding of Annex 1, ICH Q9/Q10, and FDA Process Validation guidance.
- Core Competencies: Strong analytical problem-solving, project management, and cross-functional leadership skills.
Desirable Skills
- Hands-on experience with endotoxin spiking procedures for depyrogenation tunnel qualification.
- Lean Six Sigma or CQE certification.
- Exposure to Process Analytical Technology (PAT) or digital validation tools.
Company
Morgan McKinley
Galway, Ireland
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