**Validation Engineer II** Engineering Chino, CA, US Pay Rate Low: 85000 | Pay Rate High: 100000 + Added - 01/07/2025 Apply for Job **Validation Engineer (IQ/OQ/PQ Focus)** **Salary:** $85,000–$100,000, based on experience We are seeking a **Validation Engineer** with strong Quality Systems experience to lead and support validation and internal compliance initiatives across multiple GMP production sites. This role is instrumental in ensuring the successful planning, execution, and documentation of **IQ, OQ, PQ, and cleaning validation studies** , while driving process improvements and regulatory compliance. **Key Responsibilities:** + Lead and execute **equipment and process validations** , including **Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)** protocols. + Support and coordinate **cleaning validation studies** to ensure compliance with regulatory expectations. + Partner with cross-functional teams in manufacturing, quality, and engineering to implement and optimize validation strategies. + Maintain and continuously improve the **Internal Audit Program** , training and qualifying team members to audit against applicable quality and regulatory standards. + Investigate and resolve deviations, complaints, and non-conformances through robust **root cause analysis** and **CAPA development** . + Own and manage the **CAPA system** to ensure timely closure and sustained compliance. + Analyze trends in quality data (e.g., deviations, complaints, audit findings) to inform validation and process improvement activities. + Conduct and document **Process Risk Assessments** , including PFMEAs, to proactively identify and mitigate potential issues. + Create and update **Standard Operating Procedures (SOPs)** relevant to validation and quality systems. + Ensure alignment with **FDA regulations (21 CFR 210/211)** and internal GMP policies across all validation activities. **Qualifications:** + Bachelor’s degree in Engineering, Life Sciences, or a related technical field (or equivalent work experience). + Minimum of **3 years' experience in a GMP-regulated environment** , with a focus on validation (IQ/OQ/PQ) and compliance. + Solid understanding of **validation lifecycle, CAPA management** , and GMP documentation practices. + Strong communication and technical writing skills for authoring protocols, reports, and SOPs. + Experience with quality tools and systems including Microsoft Office, Minitab, and ERP/MRP software. + Demonstrated success in **continuous improvement** and **process optimization** initiatives.This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! INDBH #LI-DNP We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.