Job Title: Sr Engineer, Validation
Location: North Little Rock, AR
Reports To: Manager - Quality Engineering
What You Will Do: The Sr. Engineer of Validation is responsible for leading the design, execution, and documentation of validation protocols (IQ/OQ/PQ) for new and existing equipment, manufacturing lines, automation systems, and cleaning processes. This role brings robust technical expertise in commissioning, qualification, and validation (CQV) within a regulated environment, along with strong leadership skills to mentor junior engineers and drive continuous improvement across our production facility.
What We Are Looking For:- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Bioengineering, Chemistry, or a related scientific/technical discipline required.
- 5-7 years of manufacturing experience (experience in commissioning, qualification, and validation (CQV) within the cosmetics, pharmaceutical, medical device, or personal care manufacturing industries preferred).
- Proven track record authoring and executing IQ/OQ/PQ protocols for manufacturing equipment (e.g., compounding vessels, filling lines, packaging equipment) and utility systems.
- Deep understanding of Good Manufacturing Practices (GMP), ISO 22716, FDA regulations, and sanitary design principles.
- Strong knowledge of statistical analysis tools and methodologies used in process validation.
- Experience with automation and control systems (PLCs, SCADA) validation is highly desirable.
- Familiarity with cleaning validation techniques, including swab/rinse sampling and analytical method parameters.
- Excellent technical writing skills with meticulous attention to detail and strong analytical, problem-solving, and root-cause analysis (RCA) capabilities.
- Effective communication and interpersonal skills, with the ability to lead cross-functional projects and mentor junior engineers and technicians.
Requirements:- Work independently to identify, investigate, and resolve validation deviations and implement sustainable CAPA solutions.
- Serve as the site expert for the deployment, commissioning, qualification, and validation (CQV) of equipment and processes.
- Possess an analytical mindset to synthesize complex validation data and statistical analysis into compliant technical plans.
- Resolve difficult technical and compliance issues on compounding, filling, packaging, and automated lines.
- Manage multiple validation projects simultaneously in a fast-paced, dynamic manufacturing environment.
The functions of Sr. Engineer, Validation include, but are not limited by the following:- Validation Strategy & Planning: Develop and execute the Master Validation Plan (MVP) for the facility. Define validation requirements for new equipment installations, automated systems, manufacturing processes, and utility systems (water, compressed air, HVAC).
- Protocol Development & Execution: Draft, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Ensure all testing aligns with internal quality standards and external regulatory requirements.
- Process & Cleaning Validation: Design and oversee process validation studies and cleaning validation programs to prevent cross-contamination and guarantee consistent product quality.
- Risk Management & Deviation Resolution: Conduct risk assessments (e.g., FMEA) to identify critical control points. Lead investigations into validation deviations, author comprehensive deviation reports, and implement robust Corrective and Preventive Actions (CAPA).
- Cross-Functional Collaboration: Partner closely with Engineering, Production, Formulation, and Quality Assurance teams to ensure seamless technology transfers, equipment commissioning, and process improvements.
- Change Control & Re-validation: Manage the validation impact of engineering change controls. Evaluate modifications to equipment, systems, or processes and determine the necessary re-validation requirements to maintain a qualified state.
- Audit Readiness & Compliance: Maintain all validation documentation in an audit-ready state. Serve as a subject matter expert (SME) during internal audits, client audits, and regulatory inspections (FDA, OSHA, ISO).
- Mentorship & Continuous Improvement: Provide guidance, training, and mentorship to junior validation engineers and technicians. Stay updated on industry trends, advancing technologies, and regulatory updates to continuously optimize validation methodologies.
What's In It For You:- Competitive Benefit Package (Medical, Dental, Vision, 401K, Pension Plan)
- Flexible Time Off (Paid Company Holidays, Paid Vacation, Vacation Buy Program, Volunteer Time, Summer Fridays & More!)
- Access to Company Perks (VIP Access to L'Oréal's Internal Shop for Discounted Products, Monthly Mobile Allowance)
- Learning & Development Opportunities (Unlimited Access to E-learnings, Lunch & Learn Sessions, Mentorship Programs, & More!)
- Employee Resource Groups (Think Tanks and Innovation Squads)
- Access to Mental Health & Wellness Programs
Don't meet every single requirement? At L'Oréal, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role but your past experience doesn't align perfectly with the qualifications listed in the job description, we encourage you to apply anyways! You may just be the right candidate for this or other roles!
