Senior Validation Lead: CSV, Equipment & QA

Celgard; Town of Harrietstown (NY); On-site; USD 95,000 - 110,000; Full time

Job summary

Bionique Testing Laboratories LLC in Saranac Lake, NY seeks a Manager for Systems and Equipment Validation to oversee the qualification or validation lifecycle of computerized systems, equipment, utilities, and related processes to ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH, GAMP, GMP, ISO).

This role ensures validation activities are properly planned, executed, and documented, maintaining quality throughout the lifecycle.

Qualifications

• Bachelor’s degree in a scientific, engineering, or related discipline.
• 5+ years of experience in quality assurance or validation within a GMP-regulated industry.
• Strong knowledge of validation principles (CSV, equipment, facilities, utilities) and applicable regulatory guidelines.
• Demonstrated experience in authoring and reviewing validation documentation.
• Excellent communication, analytical, and organizational skills.

Responsibilities

• Lead and manage qualification or validation strategies for computerized systems (CSV), laboratory information management systems, lab equipment, and utilities.
• Review and approve validation documentation including URS, risk assessments, IQ/OQ/PQ protocols, test scripts, and final reports.
• Coordinate with QA in cross-functional project teams and may represent the company’s Quality Systems with stakeholders.
• Maintain validation master plans (VMP), equipment master lists, and associated quality documentation.

Skills

Regulatory compliance

Quality Assurance

Leadership

Documentation

Risk assessment

Education

Bachelor’s degree in life sciences or engineering

Tools

LabVantage

ZenQMS

BlueMountain

Veeva

Job description

Bionique Testing Laboratories LLC in Saranac Lake, NY seeks a Manager for Systems and Equipment Validation to oversee the qualification or validation lifecycle of computerized systems, equipment, utilities, and related processes to ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH, GAMP, GMP, ISO).

This role ensures validation activities are properly planned, executed, and documented, maintaining quality throughout the lifecycle.