Senior Validation Specialist

Job Title: Senior Quality Validation Specialist

Role Overview
We are seeking a highly experienced Senior Quality Validation Specialist to provide technical leadership and quality oversight for validation activities within our highly regulated manufacturing facility. In this role, you will be responsible for the review and approval of validation protocols (IQ/OQ/PQ), change requests, and non-conformity investigations. You will serve as a subject matter expert during regulatory audits and inspections, ensuring that all equipment, systems, and processes maintain a constant state of validation and compliance. The ideal candidate is a proactive problem-solver with a deep understanding of root cause analysis and a commitment to continuous process improvement.

Key Responsibilities
• Validation Oversight: Provide quality review and approval for validation activities associated with system changes and site-wide projects. Ensure all activities align with local, corporate, and global regulatory standards.
• Protocol Management: Lead the preparation, execution, and data analysis for Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols.
• Compliance & Technical Review: Perform rigorous technical reviews of protocol data and documentation. Identify process improvements before systems are placed under formal change control.
• Investigation & Root Cause Analysis: Review and approve validation failure investigations and non-conformities using advanced root cause analysis (RCA) techniques to ensure robust corrective actions.
• Audit & Inspection Support: Present and defend validation concepts, approaches, and documentation during internal audits and external regulatory inspections.
• Change Control: Manage the quality review and approval of Change Requests (CRs) to ensure the validated state of equipment and processes is maintained throughout their lifecycle.
• Annual Product Review (APR): Manage and complete assigned Annual Product Reviews, collaborating across departments to ensure data is compliant, sufficient, and delivered on time.
• Cross-Functional Collaboration: Serve as the validation liaison in engineering, R&D, and management meetings, communicating requirements and tracking documentation status across the facility.

Qualifications & Requirements
• Education & Experience:
• PhD in Chemistry, Engineering, or a relevant field with 4+ years of related work experience.
• MA/MS in Chemistry, Engineering, or a relevant field with 6+ years of related work experience.
• BA/BS in Chemistry, Engineering, or a relevant field with 8+ years of related work experience.
• Technical Mastery:
• Extensive experience in Validation/Quality disciplines within drug development or life sciences.
• Proven expertise in authoring and reviewing IQ/OQ/PQ protocols and reports.
• Strong command of Root Cause Analysis (RCA) and failure investigation methodologies.
• Communication: Ability to communicate complex validation requirements to personnel at all levels of the organization.
• Safety: Demonstrated commitment to safety awareness and safe work practices in a laboratory or manufacturing environment.

Equal Opportunity Employer / Disabled / Protected Veterans

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For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

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We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Additional Skills

(none specified)


AllSTEM Representative Contact Info

Account Executive:


Nichols


Branch Phone:


View phone number on click.appcast.io


Location:


Ontario, CA