Validation Manager

Validation Engineer Manager

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).

Skills

Equipment validation, Pharmaceutical, process validation, Quality engineering, regulatory, risk assessment, equipment qualification, performance qualification, validation, gmp, cgmp, fda, system validation

Top Skills Details

Equipment validation, Pharmaceutical, process validation

Additional Skills & Qualifications

• 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.

• 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

Experience Level

Expert Level