Engineer, Validation

Voyant Beauty•New Albany, OH

151d

About The Position

The Validation Engineer plans, executes, and documents validation activities to ensure compliance with cGMP regulations and company quality standards. The role covers process, cleaning, equipment, and utility system qualifications for OTC products, cosmetics, and regulated systems. The engineer works with Engineering, Quality Assurance, and Operations to meet regulatory and internal requirements and supports audits and investigations with appropriate documentation and technical expertise. The role requires independently executing validation projects with minimal supervision, maintaining validation documentation and audit readiness, and staying current with regulatory guidance and validation best practices. Some duties may vary slightly by location.

Requirements

Bachelor's degree in Mechanical Engineering, Chemical Engineering, or a related technical field.
1–3 years of validation experience in a cGMP manufacturing environment, preferably in cosmetics, pharmaceuticals, or personal care.
1–3 years of experience calibrating, testing, and validating instrumentation, mechanics, and computer systems.
High proficiency in process, cleaning, equipment, and utility validation.
High proficiency in IQ/OQ/PQ protocol development and execution.
High proficiency in cGMP compliance and regulatory standards.
Medium proficiency in analytical and microbiological test interpretation.
High proficiency in SOP and technical document writing.
High proficiency in cross-functional collaboration and stakeholder communication.
Medium proficiency in root cause analysis and deviation support.
Medium proficiency in environmental monitoring and laboratory coordination.
High proficiency in equipment and computer system qualification.
Knowledge of MS Office and technical writing tools.
Applicants must be legally authorized to work in the United States without the need for sponsorship now or in the future.

Nice To Haves

Lean Six Sigma certification or training.
Validation experience in cosmetics, pharmaceutical, or personal care manufacturing.

Responsibilities

Review and approve IQ/OQ/PQ validation protocols for equipment, manufacturing processes, and cleaning procedures; develop template protocols and interim reports, and review final reports for new and existing systems, including USP water and compressed air systems.
Write, review, and maintain SOPs, validation protocols, and technical documentation; develop standards and templates for custom and regulated products.
Advise on engineering and equipment requirements for validation, especially electronic or computer-controlled systems; assist with cleanout SOPs and perform engineering testing as needed.
Participate in internal and external audits, maintain validation documentation for inspections, and provide subject matter expertise on cGMP activities.
Attend customer and cross-departmental meetings and provide technical insight on validation and compliance concerns.
Assist with environmental monitoring and coordinate with third-party laboratories; review analytical and microbial test results and methods.
Provide input on equipment purchases with validation requirements in mind.
Support quality investigations and deviations related to validation or equipment failures.
Independently execute validation projects with minimal supervision.
Remain current with regulatory guidance and validation best practices.