Validation Engineer

About the Role:
The Validation Engineering Specialist is responsible for executing qualification and validation activities supporting Over the Counter OTC pharmaceutical and personal care products, including sunscreens and skincare formulations. This role plays a critical part in ensuring manufacturing processes, equipment, utilities, facilities, and computer systems meet cGMP, FDA, and OTC regulatory requirements. The position collaborates cross functionally with Quality Assurance, Quality Control, Production, and Engineering to support new product introductions, process improvements, and ongoing compliance initiatives.

Common search terms include Validation Engineer, Validation Specialist, Process Validation, Equipment Qualification, and OTC Validation.

Responsibilities:

• Execute facility, utility, and equipment qualification activities, including IQ, OQ, and PQ protocols.
• Support process validation and process performance qualification activities for OTC and personal care manufacturing processes.
• Assist with the development, execution, and documentation of cleaning validation studies.
• Conduct computer system validation activities in alignment with regulatory and data integrity requirements.
• Support the development, review, and maintenance of validation documentation, including SOPs, protocols, reports, and batch records.
• Collaborate with Quality Assurance, Process Engineering, Production, and subject matter experts to develop and execute pFMEAs and risk assessments.
• Participate in process trials, validation runs, and pilot batches to establish robust and reliable manufacturing processes for new formulations.
• Manage assigned validation projects to ensure timely completion and alignment with project milestones.
• Prepare and present validation reports, technical summaries, metrics, and project updates to senior leadership.
• Support audit readiness by participating in internal and external audits, addressing observations, and implementing corrective and preventive actions.

Qualifications:

• Bachelors degree in chemistry, physical sciences, engineering, or a related scientific discipline.
• Minimum of three years of experience in pharmaceutical and or personal care validation, including experience in Rx or OTC manufacturing environments.
• Strong knowledge of cGMP regulations, FDA requirements, and OTC compliance standards.
• Demonstrated experience with facility, utility, and equipment qualification requirements.
• Working knowledge of process validation, process performance qualification, and cleaning validation principles.
• Experience performing computer system validation in regulated manufacturing environments.
• Proven ability to develop, execute, and maintain compliant validation systems and documentation.
• Strong technical writing, record keeping, and data analysis skills.
• Excellent communication skills with the ability to collaborate effectively across functional teams and organizational levels.

Desired Qualifications:

• Lean Six Sigma certification, Green Belt or higher.
• Experience supporting new product introductions and scale up activities in OTC or personal care manufacturing.
• Familiarity with risk management tools and methodologies used in regulated environments.
• Demonstrated leadership ability in managing validation projects and cross functional initiatives.