Validation Team Leader

Position: VALIDATION TEAM LEADER
Sinclair is looking for a  Validation Team Leader  at their Netherlands operations site.
The  Validation Team Leader  oversees the lifecycle management of equipment and systems within an ISO class 5-8 production environment, leading a team of validation engineers and serving as the Subject Matter Expert (SME) for the company on all matters of qualification and validation. This role is pivotal in ensuring that all equipment and systems are compliant with industry standards and regulatory requirements, facilitating the development and implementation of validation strategies, and maintaining documentation integrity.

Additionally, the leader is tasked with fostering a culture of continuous improvement, staying abreast of technological advancements, and ensuring that validation processes contribute to the efficiency and quality of the production environment. This role requires a blend of technical expertise, leadership skills, and a deep understanding of regulatory compliance to effectively manage the challenges of equipment qualification within a production environment.
Essential:

BSc. in Engineering, Science, or related field.
Experience in equipment qualification in a regulated environment (ISO or GMP)
Experience in qualification and validation processes
Familiarity with regulatory standards
Strong analytical and problem-solving skills
Proficiency in English language
Desirable:

Advanced degree (MSc or PhD) in a relevant field.
5+ years of experience in equipment qualification in a regulated environment
Experience in leading a team of professionals.
Certifications in quality management or validation
Project management skills
International regulatory experience
Innovative thinking
Proficiency in Dutch.
If this sounds like you and you meet the requirements, please apply; we would love to hear from you.

Key Responsibilities:

Assure 100% of the systems being qualified.
Uphold the quality of the equipment, ensuring that the medical device is produced consistently and meets predetermined specifications.
Development and execution of strategic plans for equipment qualification, in alignment with the organization’s goals and regulatory expectations.
Engage with internal and external stakeholders to ensure alignment with the applicable standards.
Manage a team of validation engineers and ensure effective collaboration across the team.
Planning, implementing, and documenting equipment qualification activities.
Maintain full documentation of all qualification activities.
Project management in the sourcing of new equipment and changes to existing equipment.
Fostering a collaborative environment that encourages professional growth and compliance with GMP.
Benefits:

A competitive salary
A 13th month
25 vacation days
8% holiday pay
Travel allowance based on €0,21 per kilometre
Retirement savings plan
We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability, and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development, and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.
This is an exciting opportunity to join a successful company, with big ambitions for the future. If this sounds like you and you meet the requirements, please apply; we would love to hear from you.

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