Global Validation Manager

In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.

Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

Global Validation Manager

As a Global Validation Manager you manage the validation and qualification approach across all our manufacturing facilities, ensuring that our processes align with industry regulations and standards.

Key Responsibilities

• Formulate and implement a global validation strategy: develop a comprehensive approach to validation and qualification that meets GMP (Good Manufacturing Practices) regulations, industry standards and customer expectations. Ensure that the strategy is aligned with corporate objectives and regulatory requirements.
• Support the development and improvement of global procedures and specific instructions for each validation/qualification subject. Collaborate on establishing validation standards for non-standard technologies. Develop templates for validation plans, protocols, and reports.
• Issue an aligned global Master-Validation-Plan and establish a report out on the execution for all stakeholders on regular base.  
• Stay informed about regulatory requirements and industry best practices : monitor changes and keep our validation strategy current and compliant with evolving standards.
• Review and approve validation protocols, reports, and related documentation to ensure accuracy, completeness, and compliance with regulatory requirements.
• Provide guidance and support to internal teams on validation and qualification matters. Develop training programs to ensure awareness and understanding of validation principles and requirements
• Collaborate with cross-functional teams to conduct risk management related to validation and qualification activities. Develop strategies to mitigate risks and ensure process robustness.
• Develop and maintain the global process control strategy in collaboration with global process engineering and relevant process owners.
• Draft project validation plans for impactful projects, to be utilized by the validation team in protocol and report writing.
• Change Control Management: Establish and maintain robust change control processes related to validation activities. Ensure that changes to equipment, processes, or facilities are properly evaluated and validated to maintain product quality and compliance.
• Data Integrity Assurance: Implement measures to ensure the integrity of validation data and documentation. Develop and maintain documentation standards for validation protocols, reports, and related documents.
• Work closely with Quality Assurance, Regulatory Affairs, Engineering, and Manufacturing teams to ensure alignment of validation activities with business objectives and regulatory requirements.

What We’re Looking For

• Bachelor’s degree in Engineering, Chemistry, Pharmacy, or related field. Advanced degree preferred.
• Minimum of 5 years of experience in validation within a GMP regulated environment, preferably in the pharmaceutical or related industry.
• Strong understanding of GMP regulations and industry standards related to validation and qualification (e.g., FDA, EMA, ICH).
• Experience in developing and implementing validation strategies across multiple sites or regions.
• Excellent project management skills with the ability to manage multiple validation projects simultaneously.
• Strong analytical and problem-solving skills, with a keen attention to detail.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Experience with validation software and tools is a plus.

What We Offer

• Attractive compensation package that rewards your expertise and impact.
• Flexible working arrangements with hybrid options to support a healthy work-life balance.
• Continuous learning and development opportunities to help you grow your skills and advance your career.
• The chance to work with cutting-edge technologies across exciting, fast-evolving industries.
• A collaborative, high-performing team environment where your ideas and contributions truly make a difference.

Ready to join us? Click “Apply”

Datwyler is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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Be yourself at Datwyler

We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.

www.datwyler.com