Validation Manager

Position Summary:

The Validation Manager is responsible for the development, execution, and maintenance of all qualification and validation activities at Bell International Laboratories, with a focus on Over-the-Counter (OTC) products, including sunscreens and skincare formulations. The role requires a strong technical and quality background in the pharmaceutical and/or personal care industry. The successful candidate will work cross-functionally with Quality Assurance, Quality Control, and Production teams to support new and ongoing validation initiatives.

Responsibilities

• Validation Master Plans
  • Develop and maintain the validation master plans for the site.
• Validation & Qualification:
  • Develop and execute Facility, Utility, and Equipment Qualifications.
  • Develop and execute Performance Qualifications and Process Validations.
  • Develop, execute, and maintain a robust Cleaning Validation program.
  • Develop, execute, and maintain a robust Computer System Validation program.
• General:
  • Develop, update, maintain SOPs and provide training as appropriate.
  • Aid Process Engineering, Quality Assurance, Production, and other SMEs in the development and execution of pFMEAs.
  • Aid other departments in process trials, validation runs, and pilot batches to establish reliable manufacturing processes for new formulations.
• Project Management:
  • Lead and manage multiple validation projects simultaneously, ensuring on-time completion.
  • Prepare and present technical reports, project updates, and validation metrics to senior management.
• Compliance & Quality:
  • Ensure qualification and validation processes comply with regulatory requirements (e.g., FDA, OTC monographs) and internal quality standards.
  • Support quality assurance initiatives by conducting risk assessments, participating in audits, and implementing corrective actions as necessary.
• Equipment & Facility Support:
  • Provide technical support for the selection, installation, and qualification of manufacturing equipment and for the development process related documentation (i.e. batch records).

Required Skills/Abilities

• Working knowledge or background in the pharmaceutical care industry.
• Working knowledge of industry best practices for risk assessment
• Working knowledge of Facility, Utility and Equipment Qualification requirements
• Working knowledge of Process Performance Qualification and Process Validation requirements.
• Working knowledge of Computer System Validation Requirements.
• Working knowledge of Cleaning Validation Requirements.
• Strong technical and/or regulatory expertise.
• Detailed record keeping and communication of results to others.
• Project skills appropriate for leadership of validation projects.
• Excellent written, verbal, and interpersonal communication skills.
• High level of initiative, innovation, critical thinking, and problem-solving skills
• Ability to work cross-functionally & at all levels within the organization including senior leadership.
• Ability to prioritize multiple responsibilities and manage deadlines accordingly.
• Communicate effectively and professionally both internally and externally.
• Exceptional attention to detail and high level of accuracy & organization.
• Ability to work as part of a team and excel independently in fast-paced environment.
• Ability to adapt quickly to changing circumstances.
• Demonstrated leadership skills.
• Proficient with Microsoft Office.

Required Education and Experience

• Bachelor’s degree in chemistry or other physical science or a related field.
• Minimum of 10 years of experience in pharmaceutical and/or personal care validation, with at least 5 years in Rx or OTC manufacturing.
• Demonstrated expertise in the development, execution, and maintenance of validation systems.
• Strong knowledge of cGMP, FDA regulations, and OTC compliance standards.

Preferred Education and Experience

• Master’s Degree preferred.
• Lean Six Sigma certification (Green Belt or higher) is a plus.

Physical Demands

• Must be able to lift up to 20 pounds on a regular basis.
• Ability to wear Personal Protective Equipment including a respirator, gloves and eye protection.
• Ability to perform work in a manufacturing environment where there is exposure to occupational hazards.