Quality (Plant) - Engineer, Hygiene Systems & Validation

The Hygiene Systems & Validation Engineer leads the site validation and contamination control strategy to ensure compliance with cGMP regulations and company quality standards. Serves as SME for hygiene systems and validation, driving continuous improvement and standardization across validation programs. Responsible for planning, executing, and overseeing validation activities including process, cleaning, equipment, and utility system qualifications for OTC products, cosmetics, and regulated systems. Partners with Engineering, Quality Assurance, and Operations to ensure validation and hygiene programs meet regulatory and internal requirements; owns audit readiness and supports regulatory inspections; mitigates contamination risks. Responsibilities include leading the validation lifecycle for new equipment, processes, and facility changes; developing and approving IQ/OQ/PQ protocols and final reports; implementing contamination control programs (cleaning validation, environmental monitoring, critical utilities); leading internal/external audits; developing SOPs and documentation; providing technical leadership; mentoring junior engineers; overseeing environmental monitoring and coordinating with third-party labs; contributing to equipment design with validation/compliance in mind; supporting investigations, deviations, and CAPA; driving continuous improvement; staying current with regulatory guidance in cGMP environments; and tailoring duties by location. A Bachelor’s degree is required, with 4-6 years of validation experience in a cGMP setting and cross-functional leadership experience; Lean Six Sigma certification is preferred.