Equipment Validator
2 weeks ago
This role requires an individual with expertise in ensuring the on-going validation and compliance of new equipment, systems, and processes. Key responsibilities include executing FAT/SAT/IOQ protocols, designing, executing, and reporting on validation studies for equipment, systems, and processes.
Responsibilities- Generating protocol reports and tracking validation progress.
- Developing and implementing validation studies to ensure compliance with industry standards.
- Providing technical interpretation and guidance on current regulations and requirements.
- Maintaining accurate records of validation documentation throughout the lifecycle.
- Supporting site change control processes and participating in external regulatory inspections.
- A minimum of 3-5 years' experience working in a healthcare manufacturing environment.
- Strong problem-solving skills and ability to work as part of a multifunctional team.
- Highly motivated and self-resilient with excellent communication skills.
- Adaptable and flexible with a strong understanding of process validation regulations.
- Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering Chemical/Mech/Elec).
- Opportunity to work on various projects and develop skills in process validation.
- Chance to participate in external regulatory inspections and improve compliance knowledge.
- Collaborative work environment with experienced professionals.
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Validation Engineer
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Waterford, Waterford, Ireland Tandem Project Management Ltd. Full timeSummaryOur client is a global biopharma company based in Waterford looking for a Validation Engineer who will be required to support new product introductions, equipment qualification and the site requalification program.The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and...
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