CQV Engineer

Ref. 1396

CQV Engineer

Our client is a leading global pharmaceutical company, and they are seeking an Equipment Validation Engineer to join their team at their site in county Galway on a 6 month contract role.

As part of the Technical Services function, the Equipment Validation Engineer - Equipment & Projects will be responsible for supporting the qualification of pharmaceutical equipment, utilities, and systems used in sterile injectable manufacturing, ensuring they remain in a validated state. This role includes the development and execution of validation protocols (IQ, OQ, PQ), supporting regulatory compliance, and collaborating with cross functional teams to ensure operational readiness.

The successful candidate must have prior experience of working in a sterile pharmaceutical environment with expertise in sterilisation validation for autoclaves, filling line and lyophilisers.

Responsibilities Equipment Qualification & Validation

• Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
• Assist in the development of URS, RTM for Equipment and automated systems.
• 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.

Sterile Manufacturing Equipment & Systems

• Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
• Hands on experience with Autoclaves.
• Execute IQ/OQ for sterilisation equipment.
• Support clean utilities qualification (e.g., WFI, clean steam, compressed air, HVAC).
• Ensure validation of automation and control systems (SCADA, PLC, MES) where applicable.

Regulatory & Compliance Support

• Author and review validation documentation, including Validation Master Plans (VMP), protocols, and reports.
• Support audits and regulatory inspections by providing validation data and technical justifications.
• Ensure adherence to Annex 1, ICH Q9 (Risk Management), ICH Q10 (Quality Systems), and FDA Process Validation Guidance.

Deviation Management & Change Control

• Investigate validation deviations and non conformances, implementing corrective and preventive actions (CAPAs).
• Assess the impact of equipment modifications and process changes on validated state.
• Collaborate with Manufacturing, Quality, and Engineering teams to ensure smooth execution of validation activities.

Continuous Improvement & Technology Upgrades

• Implement Lean and Six Sigma principles to optimize validation processes and reduce qualification cycle times.
• Evaluate requalification strategies and periodic review programmes to ensure compliance and efficiency.
• Support adoption of new technologies in aseptic processing, automation, and real time monitoring.

Perform other duties as assigned.

Requirements

• A Bachelor's Degree (level 8) or Master's Degree in relevant Engineering, Science or Technical discipline.
• 4-5 years' experience in validation, equipment qualification, or technical services within sterile injectables manufacturing.
• Prior experience of working in a sterile pharmaceutical environment with expertise in sterilisation validation for autoclaves, filling line and lyophilisers is a critical requirement.
• College level mathematics ability is required (e.g. statistical knowledge for data interpretation and planning experiments).

Technical Skills

• Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.
• Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.
• Proven 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 qualifications.
• Knowledge of autoclave and depyrogenation tunnel operation.
• Knowledge of load preparation - thermocouple calibration and placement.
• Handling of biological indicators.

Soft Skills

• Strong analytical and problem solving skills.
• Excellent communication and cross functional collaboration skills.
• Ability to manage multiple projects in a fast paced environment.
• Strong understanding of risk based approach to Equipment qualification within the pharmaceutical industry.
• Demonstrated ability to collaborate with Stakeholders to achieve optimal outcomes.
• Ability to solve moderately complex problems using established procedures and semi standardised solutions, applying analysis and some ingenuity where required.
• Strong communication and Leadership skills.

Preferred Qualifications

• Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
• Knowledge/familiarity of endotoxin spiking procedure - could help with micro resource shortage with respect to depyrogenation tunnel qualification.
• Familiarity with Process Analytical Technology (PAT) and digital validation tools.