Engineer, Validation

Voyant Beauty•New Albany, OH

13h

About The Position

The Validation Engineer is responsible for planning, executing, and documenting validation activities to ensure compliance with cGMP regulations and company quality standards. This includes process, cleaning, equipment, and utility system qualifications for OTC products, cosmetics, and regulated systems. The Validation Engineer collaborates closely with Engineering, Quality Assurance, and Operations to ensure that all validation activities meet regulatory and internal requirements and supports audits and investigations with proper documentation and technical expertise.

Requirements

Bachelor's Degree in Mechanical Engineering, Chemical Engineering or related technical field.
1-3 years in validation within a cGMP manufacturing environment (preferably cosmetics, pharmaceutical, or personal care).
1-3 years in calibrating, testing, and validating instrumentation, mechanics, and computer systems.
Process, cleaning, equipment, and utility validation (High proficiency)
IQ/OQ/PQ protocol development and execution (High proficiency)
cGMP compliance and regulatory standards (High proficiency)
SOP and technical document writing (High proficiency)
Cross-functional collaboration and stakeholder communication (High proficiency)
Equipment and computer system qualification (High proficiency)
MS Office and technical writing tools

Nice To Haves

Lean Six Sigma certification or training

Responsibilities

Review and approve validation protocols (IQ/OQ/PQ) for equipment, manufacturing processes, and cleaning procedures.
Develop template protocols, interim, 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 to ensure audit readiness and consistency.
Develop standards and templates for custom and regulated products.
Advise on engineering and equipment requirements for validation, especially electronic/computer-controlled systems.
Assist in the creation of 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.
Support departments with technical insight on validation and compliance-related concerns.
Assist with environmental monitoring activities and interface with 3rd party labs.
Review analytical and microbial test results and methods.
Provide input into equipment purchase decisions 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 best practices for validation in a regulated environment.
Some duties may vary slightly by location.