Validation Manager
About Your New Employer
- Specializes in cleanroom validation, commissioning, and compliance for the pharmaceutical, medical devices, and healthcare sectors.
- Part of a group with expertise in asset management, HVAC systems, and critical airflow applications.
About Your New Job as a Validation Manager
- Develop and implement validation plans and protocols.
- Lead validation for HVAC equipment, facilities, and lab equipment.
- Work with cross-functional teams to meet validation standards.
- Ensure compliance with FDA, EU GMP, and ISO 14644.
- Address validation issues and conduct risk assessments.
- Train and manage the validation team.
- Support tender processes with validation documentation.
- Follow up on non-conformances to ensure closure.
- Oversee project timelines, budgets, and resources.
- Promote continuous improvement in validation processes.
- Serve as the main contact for audits and maintain records.
What Skill/Experience You Need as a Validation Manager
- Engineering Qualification (Level 7 or 8 Mechanical).
- 5+ years in a lead role within a regulated environment.
- Experience in GMP manufacturing.
- Proficient in Microsoft Office.
- Strong communication and decision-making skills.
- Team player with flexibility.
- Skilled in technical writing and documentation.
What’s Next?
- Apply now by clicking “Apply Now” or contact me at pkiely@sigmar.ie
- If this job isn’t quite right but you are looking for something similar, please get in touch.
