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Overview: PM Group is an employee-owned, international project delivery firm with a team of 3,700+ people. We are world leaders in the pharma, food, medtech, and mission-critical sectors. From our network of offices in Europe, Asia, and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients, and trade partners. The PM Group now has an opportunity for a Validation Engineer (with isolator experience) to work on-site with a pharmaceutical client based in Carlow.
Responsibilities:
1. Lead and/or support validation projects and activities on-site, as directed and as appropriate.
2. Prepare validation plans in line with the strategic goals of the client and manage timely and compliant delivery of the plan.
3. Commission and validate various new technologies and new equipment.
4. Develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements.
5. Lead and support SATs.
6. Support and represent the technical quality team in meetings, visits, troubleshooting exercises, and audits.
7. Ensure manufacturing equipment is qualified in line with production schedule requirements.
8. Develop and write validation procedures according to cGMP and regulatory requirements.
9. Generate and execute validation documentation.
10. Provide continuous improvement for existing validation procedures.
11. Data collation and analysis via sophisticated computer software.
12. Sterilisation: Autoclaves, SIP of vessels; Cleaning: Parts Washer and CIP of vessels; Isolator: Filling, Sterility & Material Transfer isolators; HVAC, VHP, E-Beam, and Depyrogenation systems; Controlled Temperature Units (CTU): Temperature/Humidity Mapping; Filter Validation.
Qualifications:
1. Science/Engineering Degree and 5 years plus relevant experience including pharmaceutical isolator experience.
2. Experience in executing multiple projects and participating in cross-functional project teams.
3. Organizational skills for concurrent execution of multiple equipment/instrument, facility, and utility qualifications and projects.
4. Excellent organisation, communication, computer, and presentation skills.
5. Excellent initiative, decision-making, and ability to work in a core team environment attaining resolutions.
6. Performance and results driven.
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