Equipment Project Engineer

Role Summary:An exciting opportunity has arisen for an Equipment Project Engineer to join our client’s manufacturing facility in Co. Galway.As part of the Technical Services function the Technical Services Engineer – Equipment & Projects will be responsible for supporting the qualification of pharmaceutical equipment, utilities, and systems used in sterile injectable manufacturing are qualified and maintained in a validated state.This role involves developing and executing validation protocols (IQ, OQ, PQ), supporting regulatory compliance, and collaborating with cross-functional teams to ensure operational readiness.Core Duties and Responsibilities:Equipment Qualification & Validation:Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (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.Sterile Manufacturing Equipment & Systems:Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.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.Support adoption of new technologies in aseptic processing, automation, and real-time monitoring.Evaluate requalification strategies and periodic review programs to ensure compliance and efficiency.Perform other duties as assignedPeriodic travel is requiredMinimum Qualifications and Experience:Essential Requirements: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.Expertise in 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.Knowledge of autoclave and depyrogenation tunnel operationKnowledge of load preparation – thermocouple calibration and placement.Handling of biological indicatorsQualification of general facility equipment items and utilities systemsFamiliarity with sterile facility procedureStrong analytical and problem-solving skills, with ability to draw inferences and follow prescribed and detailed procedures to solve complex problemsAbility to carry out investigationsAbility to work independentlyExcellent communication and cross-functional collaboration abilities.Ability to manage multiple projects in a fast-paced environment.Good language skills, with ability to read/analyse/write/interpret detailed technical reports & correspondenceGood interpersonal, presentation and communication skillsPreferred QualificationsKnowledge/familiarity of endotoxin spiking procedure – could help with micro resource shortage with respect to depyrogenation tunnel qualificationLean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.Familiarity with Process Analytical Technology (PAT) and digital validation tools.