Senior Quality Validation Specialist (Life Sciences)

TL;DR

Senior Quality Validation Specialist (Life Sciences): Providing technical leadership and quality oversight for validation activities within a regulated manufacturing facility with an accent on IQ/OQ/PQ protocols, change requests, and non-conformity investigations. Focus on ensuring a constant state of validation and compliance through rigorous technical reviews and root cause analysis during regulatory audits.

Location: Onsite in Rensselaer, NY, USA

Salary: $77,000 – $114,400

Company

hirify.global is a technical staffing agency specializing in providing experienced professionals for life sciences and engineering roles.

What you will do

• Provide quality review and approval for validation activities, system changes, and site-wide projects in alignment with regulatory standards.
• Lead the preparation, execution, and data analysis for Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols.
• Perform rigorous technical reviews of protocol data and documentation to identify process improvements.
• Investigate validation failures and non-conformities using advanced root cause analysis (RCA) techniques.
• Present and defend validation concepts and documentation during internal audits and external regulatory inspections.
• Manage Change Requests (CRs) and Annual Product Reviews (APR) to ensure equipment and processes maintain a validated state.

Requirements

• Education and Experience: PhD with 4+ years, MA/MS with 6+ years, or BA/BS with 8+ years of experience in Chemistry, Engineering, or a relevant field.
• 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.
• Ability to communicate complex validation requirements to personnel at all levels of the organization.
• Location: Must be able to work onsite at the manufacturing facility in Rensselaer.

Culture & Benefits

• Major medical, dental, and vision insurance for assignments lasting 13 weeks or longer.
• 401k plan availability for long-term assignments.
• Statutory sick pay where required.
• Strong commitment to safety awareness and safe work practices in laboratory and manufacturing environments.
• Provision of reasonable accommodations for individuals with disabilities.