About The Role

Join our clients site based in Carlow as a Validation Engineer and contribute to their dynamic team in a cGMP regulatory environment. Your role will involve supporting various aspects of Validation, including Sterilization, Cleaning, Isolator systems, Controlled Temperature Units, and Filter Validation.

Main Responsibilities

• Provide project validation support, including conducting equipment performance qualifications (e.g., cleaning and sterilization validation).
• Develop project validation master plans, update SOPs and documentation.
• Author validation protocols and final reports, execute validation studies, and analyse validation data.
• Independently resolve technical issues encountered during study execution.
• Work within cross-functional teams to achieve validation project objectives.
• Operate with moderate work direction, leveraging your skills and knowledge in the position.
• Create, review, and execute qualification/validation documentation and cycle development studies as per the standard process.
• Address technical issues during study execution and contribute to investigations.
• Collaborate with Production, Maintenance, and Quality teams during Cycle Development & Performance Qualification activities.
• Analyse system failures, perform root cause analysis, and drive continuous improvement.
• Ensure compliance with policies, regulations, and cGMP practices.
• Represent the validation team in cross-functional projects and technical forums.

Requirements

• Relevant technical qualification in Pharmaceutical/Biological/Chemical sciences or Engineering.
• Experience in a similar role within GMP manufacturing.
• Knowledge of CTU equipment qualification and thermal mapping.
• Strong skills in deviation management, change control, and project leadership.
• Familiarity with process monitoring systems, automation (DeltaV), and data systems (Pi System) beneficial.
• Proficiency in analysing complex data and generating reports.
• Expertise in equipment and process validation, sterile fill-finish processes, and equipment.
• Excellent communication and interpersonal skills.
• Proficiency in Microsoft Office and related computer applications.

Advantageous Skills

• Equipment Periodic Validation and Validation Lifecycle. Project Management qualifications.
• Expertise in Filter Validation, Autoclave/SIP Sterilization, Isolator Qualification, and Cleaning Validation.
• Knowledge of Temperature Mapping and Vial/Syringe Processing Technologies.

For further information on this role please contact Maraleeze Keane on 0864410614 /recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website - https://www.hero.ie/

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.