Global Validation Supervisor

Hollister Incorporated; Bearnadearg; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

The Validation Supervisor at Hollister Incorporated leads a site‑based team of Validation Quality Engineers and is accountable for the planning, coordination, and execution of equipment and process validation activities in support of new product introductions, change control, and strategic initiatives within a regulated manufacturing environment.

The role partners with Design Assurance, Engineering, Manufacturing, and Quality teams to ensure validation activities comply with the Quality

Competenze

• Bachelor’s Degree with 8-12 years of related experience.
• Bachelor’s degree in Engineering, Science, or related discipline, or equivalent experience.
• Typically 8-12 years of experience in validation, quality engineering, or a related role within a regulated industry.
• Demonstrated experience working in medical device, pharmaceutical, or similarly regulated manufacturing environments.
• Prior experience leading or supervising technical or quality teams is required.
• Certified Quality Engineer (CQE) or equivalent professional certification, or advanced technical degree.

Mansioni

• Lead and supervise a team of Validation Quality Engineers, providing coaching, mentoring, and performance guidance.
• Plan and coordinate execution of equipment, process, and test method validations supporting new product development, change control, and strategic initiatives.
• Ensure validation activities are performed in accordance with internal procedures, regulatory requirements, and industry best practices.
• Review and approve validation documentation, including validation plans, risk assessments, protocols, reports, and deviation or exception documentation.
• Allocate resources and manage timelines to support project schedules and operational priorities.
• Act as site validation liaison with Design Assurance, R&D, Engineering, Manufacturing Operations, Supply Chain, and Quality functions.
• Support compliance activities including internal audits, inspections, and corrective and preventive action (CAPA) processes.
• Identify and drive continuous improvement opportunities related to validation processes, standard work, and compliance practices.
• Perform additional quality or validation‑related duties as assigned by management.

Conoscenze

Leadership

Validation planning

Regulatory compliance

Documentation review

CAPA processes

Continuous improvement

Cross-functional collaboration

Formazione

Bachelor’s degree in Engineering/Science

8–12 years related experience

CQE or equivalent certification

Strumenti

Statistical analysis

Descrizione del lavoro

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We Make Life More Rewarding and Dignified

Location: Ballina
Department: Quality

Summary

The Validation Supervisor leads a site‑based team of Validation Quality Engineers and is accountable for the effective planning, coordination, and execution of equipment and process validation activities in support of new product introductions, change control, and strategic initiatives. The role partners closely with Design Assurance, Engineering, Manufacturing, and Quality teams to ensure validation activities are executed in compliance with the Quality Management System and applicable regulatory requirements. This position plays a critical role in maintaining a compliant validated state and enabling the reliable delivery of high‑quality products within a regulated manufacturing environment.

Responsibilities

• Lead and supervise a team of Validation Quality Engineers, providing coaching, mentoring, and performance guidance.
• Plan and coordinate execution of equipment, process, and test method validations supporting new product development, change control, and strategic initiatives.
• Ensure validation activities are performed in accordance with internal procedures, regulatory requirements, and industry best practices.
• Review and approve validation documentation, including validation plans, risk assessments, protocols, reports, and deviation or exception documentation.
• Allocate resources and manage timelines to support project schedules and operational priorities.
• Act as site validation liaison with Design Assurance, R&D, Engineering, Manufacturing Operations, Supply Chain, and Quality functions.
• Support compliance activities including internal audits, inspections, and corrective and preventive action (CAPA) processes.
• Identify and drive continuous improvement opportunities related to validation processes, standard work, and compliance practices.
• Perform additional quality or validation‑related duties as assigned by management.

• Lead and develop validation personnel to deliver project and compliance objectives.
• Apply problem‑solving, critical thinking, and risk‑based decision‑making in a dynamic manufacturing environment.
• Communicate complex technical information clearly to diverse stakeholders, including senior leadership.
• Manage multiple priorities while maintaining attention to detail and adherence to quality standards.
• Collaborate effectively across functions and organizational levels to achieve shared goals.
• Maintain a strong commitment to quality, integrity, and continuous improvement.

Essential Functions of the Role

• Translating technical findings into business-relevant insights.
• Manage multiple priorities and deadlines in a fast‑paced environment.
• Collaborate with cross‑functional teams (Regulatory, Marketing, Market Access).

Education & Work Requirements

• Bachelor’s Degree with 8-12 years of related experience

Education & Work Preferences

• Bachelor’s degree in Engineering, Science, or a related discipline, or equivalent experience.
• Typically 8-12 years of experience in validation, quality engineering, or a related role within a regulated industry.
• Demonstrated experience working in medical device, pharmaceutical, or similarly regulated manufacturing environments.
• Prior experience leading or supervising technical or quality teams is required.

• Certified Quality Engineer (CQE) or equivalent professional certification.
• Advanced degree in a technical or scientific discipline.
• Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11, and related regulatory standards.
• Experience with statistical analysis and validation tools.
• Demonstrated experience supporting audits and regulatory inspections.

• Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
• Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do.
• Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
• Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
• Live The Schneiders’ Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.

About Hollister Incorporated
Hollister Incorporated is an independent, employee‑owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services and by its Vision to grow and prosper as an independent, employee‑owned company, and in the process, to become better human beings.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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