Validation Engineer

Description

Position Summary:

The Validation Engineer is responsible for the execution of 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.

Key Responsibilities:

• Perform Facility, Utility, and Equipment Qualifications.
• Assist in executing Performance Qualifications and Process Validations.
• Support the implementation and documentation of Cleaning Validation activities.
• Conduct Computer System Validations.
• Assist with updating SOPs and participate in training sessions as needed.
• 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.
• Execute validation projects as assigned, ensuring on-time completion.
• Prepare and present technical reports, project updates, and validation metrics to senior management.
• 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.
• Provide technical support for the selection, installation, and qualification of manufacturing equipment and for the development process related documentation (i.e. batch records).

Requirements

Required Skills/Abilities:

• Background in the pharmaceutical industry.
• Familiarity with industry best practices for risk assessment.
• Knowledge of Facility, Utility and Equipment Qualification requirements.
• Understanding 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 5+ years of experience in pharmaceutical and/or personal care validation, with at least 2 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:

• Lean Six Sigma certification (Green Belt or higher) is a plus.