Join to apply for the Manager Validation role at SEKISUI Diagnostics.
Overview
This key position reports directly to the Head of Quality and plays a vital role in guiding a high-performing team committed to securing cGMP certification for the organization. The ideal candidate will be responsible for leading the design, execution, and continuous improvement of validation systems and processes while recruiting and mentoring team members to achieve optimal performance and operational excellence.
Responsibilities
* Co‑ordinating and performing validation project activities for all facilities, equipment and processes operated in compliance with EudraLex Volume 4 – Good Manufacturing Practice (GMP) guideline requirements and other applicable quality system requirements.
* Establishing and maintaining best practices for departmental procedures to ensure effectiveness to validation requirements.
* Providing direction and expertise in the management of validation activities.
* Preparing, executing and reporting validation protocols.
* Rationalise validation documentation (and protocol requirements) to ease routine validation activities while validation requirements are met.
* Liaise with Engineering, Quality Assurance and User Departments to ensure that validation is conducted in a timely manner with minimal disruption to production.
* Maintaining an awareness of regulatory developments in the validation field and brief Operative personnel as appropriate.
* Attend meetings, both internal and external, representing the department in a professional manner.
* Ensure review and update of validation procedures (Policies, Master plans, Standard Operating Procedures (SOP’s)) for equipment and facilities.
* Participate in audits by customers and regulatory authorities.
Qualifications
* Specific knowledge of EudraLex Volume 4, including validation requirements in Annex 1, 11, 15 and Bio‑pharmaceutical cleaning validation.
* Experience in managing people.
* Ability to author and execute validation reports.
* Typical requirement: a scientific university degree and a minimum of 10 years of validation and GMP related experience.
Benefits
SEKISUI Diagnostics offers a competitive compensation and benefits package, including opportunities for professional growth and the chance to contribute to high‑quality diagnostic solutions.
Equal Opportunity Employment
As an equal opportunity employer, SEKISUI Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non‑job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also SEKISUI Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.
SEKISUI Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.
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