NPI & Laboratory Supervisor
Today Wexford-Wexford, Ireland
About us
https://www.waters.com/nextgen/us/en.html
- Size: 5,001 - 10,000 employees
- Industry: Information Technology
Overview
Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service.
We are seeking an experienced and motivated leader to drive the successful transfer, scale-up, and ongoing support of innovative diagnostic products within a regulated manufacturing environment. This is a unique opportunity to bridge development and operations, leading critical activities including design transfer, process validation, equipment qualification, stability programs, product release to new markets, and continuous improvement initiatives.
Responsibilities
Lead product transfers and releases into new markets and geographies.
Oversee equipment qualification, validation, and lifecycle management.
Manage design transfer activities from development through manufacturing operations.
Lead process validation activities and transfer of Critical-to-Quality (CTQ) attributes to manufacturing.
Manage stability programs, stability extensions, and trending activities for product lots.
Develop and monitor Laboratory Operations KPIs to drive performance and continuous improvement.
Review and approve technical and quality documentation.
Lead process improvement initiatives and operational excellence projects. Support customer evaluations, clinical validations, and field activities. Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable global regulatory requirementsLead audit readiness and support internal and external audits.
Manage quality systems including Non-Conformance, Change Control, CAPA, and TrackWise processes.
Qualifications
Education:
Minimum BSc Hons in relevant life science subject.
Experience:
Proven experience of working in an operations environment.
Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
Competencies:
Proven experience of working in an operations environment
Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.
Microsoft excel training or substantial experience utilizing excel is required.
Understanding of the requirements of quality management systems- ISO13485 & 21CFR820
Knowledge of Non-Conformance, Change Control and CAPA systems
Company Description
Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.
Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service.
We are seeking an experienced and motivated leader to drive the successful transfer, scale-up, and ongoing support of innovative diagnostic products within a regulated manufacturing environment. This is a unique opportunity to bridge development and operations, leading critical activities including design transfer, process validation, equipment qualification, stability programs, product release to new markets, and continuous improvement initiatives.
Responsibilities
Lead product transfers and releases into new markets and geographies.
Oversee equipment qualification, validation, and lifecycle management.
Manage design transfer activities from development through manufacturing operations.
Lead process validation activities and transfer of Critical-to-Quality (CTQ) attributes to manufacturing.
Manage stability programs, stability extensions, and trending activities for product lots.
Develop and monitor Laboratory Operations KPIs to drive performance and continuous improvement.
Review and approve technical and quality documentation.
Lead process improvement initiatives and operational excellence projects. Support customer evaluations, clinical validations, and field activities. Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable global regulatory requirementsLead audit readiness and support internal and external audits.
Manage quality systems including Non-Conformance, Change Control, CAPA, and TrackWise processes.
Qualifications
Education:
Minimum BSc Hons in relevant life science subject.
Experience:
Proven experience of working in an operations environment.
Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
Competencies:
Proven experience of working in an operations environment
Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.
Microsoft excel training or substantial experience utilizing excel is required.
Understanding of the requirements of quality management systems- ISO13485 & 21CFR820
Knowledge of Non-Conformance, Change Control and CAPA systems
Company Description
Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.
Additional Information
- Posted: today