Quality Assurance Validation Specialist

Kelly® Science & Clinical is seeking an experienced Quality Assurance Validation Specialist for a contract-to-hire opportunity with one of our clients, a leading small molecule CDMO at their Irvine, CA facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Position Title: Quality Assurance Validation Specialist

Position type: Contract-to-hire

Workplace: Onsite in Irvine, CA.

Salary: $38-43 per hour

Overview

Join our dynamic pharmaceutical quality team as a QA Validation Specialist, where you’ll play a pivotal role in ensuring that our facility, manufacturing, packaging, and laboratory operations adhere to the highest cGMP standards. As a key contributor, you’ll directly impact the quality, compliance, and integrity of our products and processes through expert validation and engineering practices.

Responsibilities

• Drive the qualification and validation of facility infrastructure, manufacturing operations, packaging lines, and laboratory equipment to maintain regulatory compliance and industry-leading quality standards.
• Author, review, and execute robust qualification and validation protocols and reports, ensuring all documentation meets or exceeds cGMP and regulatory expectations.
• Strategically plan and coordinate Performance Qualifications, routine calibration, and maintenance activities for equipment, utility systems, and analytical instruments in close partnership with Operations, QC, Engineering, and Maintenance teams.
• Support vendor selection and procurement processes by qualifying vendors, contributing insights into User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and Design/Data Design Specifications (DDS).
• Manage and routinely update the Validation Master Plan, ensuring alignment with evolving site requirements and regulatory guidance.
• Confidently present qualification and validation documentation during regulatory inspections and client audits, clearly articulating technical concepts and outcomes.
• Champion the ongoing design, implementation, and continual improvement of validation procedures, fostering a culture of compliance and operational excellence.
• Provide expert guidance and technical leadership on qualification best practices, acting as a resource for Production, Quality, and cross-functional stakeholders.
• Oversee and direct contract specialists and external service providers, ensuring project outcomes are on time, on budget, and in compliance.
• Analyze, summarize, and effectively communicate study data and qualification outcomes in concise, inspection-ready reports.
• Develop and execute matrix-based validation strategies for complex processes and equipment, backed by scientifically justified rationales.
• Lead investigations into exceptions, deviations, and non-conformances, driving root cause analyses and effective resolution in support of ongoing quality initiatives.
• Take ownership of special projects and other duties as assigned, adapting to business priorities and customer requirements.

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Engineering, or related field) required.
• Minimum of 5 years’ direct experience in a highly regulated pharmaceutical, biotechnology, or related cGMP environment.
• Demonstrated expertise in qualification and validation of commercial manufacturing and packaging equipment.
• Proven project management skills with a strong track record of completing projects to specification, on schedule, and within budget constraints.
• Comprehensive working knowledge of cGMP standards, regulatory expectations (FDA, EMA, etc.), and industry guidance for validation activities.
• Experience with authoring and reviewing SOPs, GMP documentation, protocols, and regulatory submissions with a focus on accuracy, traceability, and compliance.
• Strong analytical, troubleshooting, and communication skills; able to navigate complex technical challenges and provide clear, actionable guidance.

Elevate your validation engineering career and make a measurable impact—apply to join our leadership team in quality assurance today

What happens next:

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.