Validation Manager

About the Role

The Validation Manager is responsible for overseeing the qualification and validation of Over-the-Counter (OTC) products, including sunscreens and skincare formulations. This role involves developing, executing, and maintaining validation programs that comply with regulatory and quality standards. Collaboration with Quality Assurance, Quality Control, and Production teams is essential to support both new and ongoing validation initiatives. A strong technical background in pharmaceutical or personal care manufacturing is critical for success in this position.

Responsibilities:

• Create and manage validation master plans.
• Execute Facility, Utility, and Equipment Qualifications, as well as Performance and Process Validations.
• Develop and maintain Cleaning Validation and Computer System Validation programs.
• Update and manage Standard Operating Procedures (SOPs) and provide necessary training.
• Conduct risk assessments and support process engineering efforts such as pFMEAs.
• Oversee multiple validation projects, ensuring timely completion and compliance with quality standards.
• Prepare and present technical reports and validation metrics to senior leadership.
• Provide technical support for equipment selection, installation, and documentation development.

Qualifications:

• Bachelors degree in chemistry, engineering, or a related physical science.
• At least 10 years of validation experience in pharmaceutical or personal care industries, with 5 years focused on OTC or Rx manufacturing.
• Strong knowledge of cGMP, FDA regulations, and OTC compliance.
• Proven ability to lead validation projects and work collaboratively across departments.
• Proficiency with Microsoft Office and strong communication skills.

Preferred Qualifications:

• Masters degree in a related field.
• Lean Six Sigma certification (Green Belt or higher).
• Advanced Microsoft Excel skills and experience with process improvement methodologies.
• Leadership experience in senior-level manufacturing roles.