Laboratory Validation Specialist

Astrix; City of Rensselaer (NY); On-site; USD 75,768 - 103,320; Full time

Job summary

Astrix is seeking a Laboratory Validation Specialist located in Rensselaer, NY. This contract position will support validation and quality activities in a GMP-regulated pharmaceutical environment. The ideal candidate has over 6 years of relevant experience in validation and QA, especially in lab equipment and API processes. Responsibilities include developing and reviewing validation protocols, ensuring compliance with cGMP and FDA standards, and supporting audits and inspections. Pay ranges from $55 to $75 per hour, based on experience.

Qualifications

• 6+ years of validation, QA, or pharmaceutical/biotech manufacturing experience.
• Strong experience with IQ/OQ/PQ and GMP environments.
• Strong understanding of cGMP and FDA requirements.

Responsibilities

• Provide quality review and approval of validation activities.
• Develop, execute, and review IQ, OQ, and PQ validation protocols.
• Support root cause analysis and non-conformance resolution.

Skills

Validation experience

GMP knowledge

Strong documentation skills

Communication skills

Job description

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)

Requirements

• 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

Nice to Have

• Experience in API or small molecule manufacturing
• Familiarity with LIMS, TrackWise, 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!