Validation Manager

Perrigo•New York, NY

About The Position

The Validation Manager is responsible for Perrigo’s Qualification and Validation program at its New York facility. The role oversees a team of Validation Engineers and their work qualifying and validating manufacturing and packaging equipment and processes for over-the-counter semi-solid creams, ointments and gels, suppositories, and nasal sprays. The Manager leads colleagues in designing, managing, and executing projects, determines validation requirements for complex operational issues, and coordinates key projects and technical documentation. The role also leads cross-functional compliance and continuous-improvement initiatives and provides validation-related reports for audits and agency inspections.

Requirements

Bachelor’s degree in a scientific field.
Five or more years of progressively responsible experience with increasing breadth and/or depth.
Pharmaceutical industry experience.
Supervisory experience.
Experience in Validation, Quality, or Operations.
Thorough understanding of validation processes and the interpretation and application of FDA and cGMP requirements.
Demonstrated ability in validation techniques, practices, precedents, theory, and principles.
Excellent written and oral communication skills.

Responsibilities

Oversee Validation Engineers performing qualification and validation of manufacturing and packaging equipment and processes at the Perrigo New York facility.
Determine validation requirements for complex operational issues.
Evaluate, design, develop, and coordinate key projects.
Develop and write technical documents.
Lead the resolution of complex problems to achieve goals.
Identify and lead cross-functional departments in compliance and continuous-improvement initiatives.
Provide audit and agency-inspection reports related to validation requirements and activities.