validation manager
validation manager
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Job Description
Validation Manager
We are seeking an experienced Validation Manager to oversee qualification and validation activities focusing on OvertheCounter products. This role requires a strong technical and quality background in pharmaceuticals and/or personal care manufacturing. The ideal candidate will work crossfunctionally with Quality Assurance Quality Control and Production teams to support validation initiatives.
Key Responsibilities
Validation & Qualification- Develop and maintain Validation Master Plans for the site.
- Oversee Facility Utility and Equipment Qualification processes.
- Lead Performance Qualifications and Process Validations to ensure manufacturing consistency.
- Implement and maintain a Cleaning Validation program.
- Manage Computer System Validation (CSV) efforts.
- Ensure all validation activities comply with FDA regulations cGMP standards and OTC monographs.
- Conduct risk assessments participate in audits and support corrective actions.
- Maintain and update Standard Operating Procedures (SOPs) while providing training as needed.
- Manage multiple validation projects from planning through .
- Lead process trials validation runs and pilot batches to support manufacturing improvements.
- Work closely with crossfunctional teams to establish robust and compliant processes.
- Provide technical expertise for equipment selection installation and qualification.
- Support the development of batch records and process documentation.
Required Skills & Experience
- Strong knowledge of cGMP FDA regulations and OTC compliance standards.
- Expertise in risk assessment validation methodologies and regulatory compliance.
- Handson experience with process validation cleaning validation and computer system validation.
- Excellent project management skills with the ability to handle multiple priorities.
- Strong communication skills with the ability to work crossfunctionally and influence decisionmaking.
- Proficiency in Microsoft Office and validationrelated software.
Education & Experience Requirements
- Bachelors degree in Chemistry Engineering or a related field.
- 10 years of validation experience in the pharmaceutical and/or personal care industry.
- 5 years of experience in OTC or Rx manufacturing validation.
Preferred Qualifications
- Masters degree in a related field.
- Lean Six Sigma certification (Green Belt or higher) is a plus.
Work Environment & Physical Demands
- Ability to lift up to 20 lbs as needed.
- Must be able to wear Personal Protective Equipment (PPE) including respirators gloves and eye protection.
- Comfortable working in a manufacturing environment with potential occupational hazards.
Required Experience:
Manager
Employment Type
Full Time
