Global Validation Leader - Drive Compliance & Quality

Hollister Incorporated; Bearnadearg; On-site; EUR 90,000 - 120,000; Full time

Job summary

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

Qualifications

• 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.

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.

Skills

Leadership

Validation planning

Regulatory compliance

Documentation review

CAPA processes

Continuous improvement

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Science

8–12 years related experience

CQE or equivalent certification

Tools

Statistical analysis

Job description

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