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.
- 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.
- 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.
- 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 /email@example.com
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