Laboratory Validation Specialist
Job in
City of Rensselaer, Rensselaer County, New York, USA
Listed on 2026-10-14
Listing for:
Astrix
Full Time
position Listed on 2026-10-14
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Quality Engineering
Job Description & How to Apply Below
We are seeking a Laboratory Validation Specialist to support validation and quality activities within a GMP-regulated pharmaceutical environment with a focus on lab equipment, API manufacturing processes, and validation lifecycle support.
Location: Rensselaer, NY
Pay: $55–$75/hr DOE
Type: Contract (Potential Extension/Conversion)
Key Responsibilities- Provide quality review and approval of validation activities related to equipment, systems, and process changes
- Develop, execute, and review IQ, OQ, and PQ validation protocols and reports
- Review and approve validation documentation, change controls, and deviation investigations
- Support root cause analysis and non-conformance resolution
- Ensure validated state of equipment through documentation and compliance review
- Support audits, inspections, and regulatory readiness activities
- Partner with QA, Engineering, and R&D on validation strategy and execution
- Maintain accurate validation records and support Annual Product Reviews (APR)
- 6+ years of validation, QA, or pharmaceutical/biotech manufacturing experience
- Strong experience with IQ/OQ/PQ and GMP environments
- Background in lab equipment validation and/or API manufacturing preferred
- Experience with change control, deviations, and audits
- Strong understanding of cGMP and FDA requirements
- Strong documentation and communication skills
- Experience in API or small molecule manufacturing
- Familiarity with LIMS, Track Wise, or similar quality systems
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!
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