Validation Engineer Global External Manufacturing

Coopers Group AG seeks a Senior Validation Engineer in Zug to oversee qualification and validation activities for global external manufacturing suppliers, ensuring compliance with quality standards.

This position focuses on the rigorous review and evaluation of qualification and validation documentation submitted by external manufacturing partners. The engineer provides critical oversight of deviation assessments and supports continuous process improvement through technical expertise and data analysis.

Responsibilities

• Assess qualification and validation records along with process risk analyses submitted by suppliers.
• Monitor and evaluate deviations arising from qualification and validation processes.
• Record evaluation results in strict adherence to established quality protocols.
• Drive process enhancements by delivering technical guidance and conducting statistical data reviews.
• Provide specialized counsel to suppliers regarding quality assurance and regulatory compliance.
• Work closely with internal cross-functional teams to meet shared objectives.

Requirements

• Hold a Bachelor’s degree in engineering or a scientific/technical discipline, or possess equivalent professional experience.
• Demonstrate a minimum of 10 years in quality assurance, auditing, or validation roles within the pharmaceutical or medical device sectors.
• Have at least 5 years of experience managing external manufacturing operations.
• Possess deep knowledge of relevant industry standards and regulatory norms.
• Show strong proficiency in injection molding, blow molding, or similar automated production methods.
• Communicate fluently and professionally in both English and German, in writing and speech.

Nice to have

• Understanding of computerized systems validation and controlled environment qualification per ISO 14644.
• Familiarity with product risk management frameworks outlined in ISO 14971.
• Certification as a Lean Six Sigma Green Belt or Black Belt.

About the company

Coopers Group AG fosters a workplace culture that prioritizes the ongoing pursuit of knowledge and professional growth for all team members.

• Emphasis on continuous learning and self-improvement for employees.