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We are seeking a highly skilled Senior Validation Specialist to join our team in Carlow. The successful candidate will lead and/or support validation projects, prepare validation plans, and manage timely delivery.
Responsibilities- Lead and/or support validation projects and activities on site as directed.
- Prepare validation plans aligned with client goals and manage timely delivery.
- Commission and validate new technologies and equipment.
- Develop and execute Commissioning & Qualification lifecycle protocols.
- Support SATs and represent the technical quality team in meetings and visits.
- Ensure manufacturing equipment is qualified in line with production requirements.
- Develop and write validation procedures according to cGMP and regulatory requirements.
- Generate and execute validation documentation.
- Science/Engineering Degree and 5+ years relevant experience with isolator experience.
- Experience executing multiple projects and participating in cross-functional project teams.
- Organizational skills for concurrent execution of multiple equipment/instrument, facility and utility qualifications and projects.
- Excellent organization, communication, computer, and presentation skills.
- Excellent initiative, decision-making, and ability to work in a core team environment.
