About the Company:
This company specializes in cleanroom validation, commissioning, and compliance for the pharmaceutical, medical device, and healthcare sectors.
Job Summary:
The Validation Manager will be responsible for planning, coordinating, and executing validation activities, ensuring compliance with regulatory standards and internal quality policies. The role includes developing validation procedures, managing reports, supporting tender submissions, and driving process improvements. The Validation Manager will work closely with the General Manager, Operations Manager, and HVAC Services Lead to support business growth and strategic objectives.
Key Responsibilities:
1. Develop and execute validation plans, including IQ, OQ, and PQ protocols, in compliance with industry regulations.
2. Lead validation efforts for HVAC equipment, lab equipment, and utility systems.
3. Collaborate with cross-functional teams (Quality Assurance, Engineering, Manufacturing) to define and implement validation requirements.
4. Ensure compliance with FDA, EU GMP, ISO 14644, and other applicable standards.
5. Identify and resolve validation-related issues, conducting risk assessments and implementing remediation plans.
6. Oversee training and development of the validation team, ensuring high competency and compliance standards.
7. Provide technical validation support for tender processes, including preparing validation documentation for bid submissions.
8. Conduct validation follow-ups to ensure timely closure of identified actions and non-conformances.
9. Manage validation project timelines, budgets, and resources effectively.
10. Drive continuous improvement initiatives within validation processes.
11. Act as the primary contact for internal and external audits related to validation activities.
12. Ensure proper maintenance of validation, calibration, and maintenance records.
Qualifications:
1. Level 7 or Level 8 qualification in Mechanical Engineering or a related field.
2. Minimum of 5 years' experience in a lead role within a regulated environment.
3. Experience working in a GMP manufacturing environment.
4. Proficient in Microsoft Office (Excel, Word, PowerPoint).
5. Strong communication skills, with the ability to influence and make confident decisions.
6. Team player with a flexible approach but also capable of working independently.
7. Strong technical writing skills and ability to interpret technical documentation.
8. Full, clean driving license required.
9. Must be eligible to work in Ireland.
What’s Next?
Apply now by clicking “Apply Now” or contact me at +353 21 461 5740 or email pkiely@sigmar.ie.
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