Laboratory Validation Specialist
Astrix Technology, Rensselaer, NY, United States
Laboratory Validation Specialist
Laboratory
Rensselaer, New York, US
Added - 23/04/2026
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!
INDBH
#LI-CS1
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Laboratory
Rensselaer, New York, US
Added - 23/04/2026
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!
INDBH
#LI-CS1
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.