A Brief OverviewThe Hygiene Systems & Validation Engineer leads the site validation and contamination control strategy to ensure compliance with cGMP regulations and company quality standards. This role serves as the subject matter expert (SME) for hygiene systems and validation, driving continuous improvement and standardization across validation programs. This position is responsible for planning, executing, and overseeing validation activities including process, cleaning, equipment, and utility system qualifications for OTC products, cosmetics, and regulated systems. The Engineer, Validation Technical partners closely with Engineering, Quality Assurance, and Operations to ensure validation and hygiene programs meet regulatory and internal requirements. The role also owns audit readiness and supports regulatory inspections, while proactively mitigating contamination risks across the site.
What you will do- Lead the validation lifecycle strategy for new equipment, manufacturing processes, and facility changes, including development, standardization, and approval of IQ/OQ/PQ protocols and final reports.
- Define, implement, and continuously improve site-wide contamination control programs, including cleaning validation, environmental monitoring, and critical utility systems (e.g., USP water, compressed air).
- Own audit readiness for validation and hygiene systems, serving as the primary SME during internal and external audits and regulatory inspections.
- Develop, review, and maintain SOPs, validation protocols, and technical documentation to ensure compliance, consistency, and inspection readiness.
- Provide technical leadership and cross-functional support to Engineering, Quality, and Operations on validation, hygiene, and compliance-related initiatives.
- Mentor and provide guidance to junior engineers and technicians, supporting development of validation and quality capabilities across the site.
- Lead environmental monitoring oversight and interface with third-party laboratories; evaluate microbial and analytical data to assess risk and ensure program effectiveness.
- Provide input into equipment design and purchase decisions with validation and compliance requirements in mind
- Support quality investigations, deviations, and CAPA related to validation or equipment failures
- Drive continuous improvement initiatives across validation and contamination control programs
- Remain current with regulatory guidance, industry best practices, and emerging risks in cGMP environments
- Some duties may vary slightly by location
Education Qualifications- Bachelor's Degree Mechanical Engineering, Chemical Engineering, or related technical field (Required)
Experience Qualifications- 4-6 years Validation experience within a cGMP manufacturing environment (OTC, pharmaceutical, cosmetics, or personal care) (Required)
- 4-6 years Cross-functional project leadership across engineering, quality, and operations (Required)
- 4-6 years FDA/OTC regulated environments (Preferred)
- 4-6 years Leading audits, inspections, and regulatory interactions (Preferred)
Skills and Abilities- Process, cleaning, equipment, and utility validation (High proficiency)
- IQ/OQ/PQ protocol development and execution (High proficiency)
- cGMP compliance and regulatory standards (High proficiency)
- Regulatory inspection leadership (FDA and customer audits) (High proficiency)
- Risk-based validation strategy and decision making (High proficiency)
- Contamination control program ownership (cleaning, EM, utilities) (High proficiency)
- SOP and technical document development (High proficiency)
- Cross-functional collaboration and stakeholder influence (High proficiency)
- Influencing without authority across functions (High proficiency)
- Project leadership and prioritization across multiple initiatives (High proficiency)
- Root cause analysis and deviation/CAPA support (Medium proficiency)
- Environmental monitoring and lab coordination (Medium proficiency)
- Analytical and microbiological test interpretation (Medium proficiency)
Licenses and Certifications- Lean Six Sigma certification or equivalent training (Preferred)
