Senior CSV & Equipment Validation Lead

Bionique Testing Laboratories LLC; 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 lead qualification and validation of computerized systems, equipment, and utilities, ensuring compliance with FDA, EMA, ICH, GAMP, GMP, and ISO standards.

You will oversee CSV, IQ/OQ/PQ, review validation documents, coordinate with QA, support audits, and mentor staff, driving lifecycle documentation, risk assessments, CAPAs, and KPI reporting to sustain validated state across the

Qualifications

• Bachelor’s degree in a scientific, engineering, or related technical discipline.
• 5+ years of QA or validation experience in GMP-regulated industry.
• Strong knowledge of CSV, equipment, facilities, and utilities validation.
• Experience authoring and reviewing validation documentation.
• Excellent communication, analytical, and organizational skills.
• Familiarity with quality systems such as LabVantage, ZenQMS, BlueMountain, Veeva is a plus.
• Certification or training in GAMP, risk-based validation, or data integrity is advantageous.

Responsibilities

• Lead qualification/validation strategies for computerized systems and lab equipment.
• Review URS, IQ/OQ/PQ protocols, risk assessments, and final reports.
• Coordinate with QA and participate in change control, deviations, and CAPAs.
• Support internal/external audits and maintain regulatory knowledge.
• Coach and develop team members; collaborate with cross-functional stakeholders.
• Maintain validation master plans and KPIs for validation activities.

Skills

Communication

Analytical

Organizational skills

Team collaboration

Education

Bachelor’s degree in science/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 lead qualification and validation of computerized systems, equipment, and utilities, ensuring compliance with FDA, EMA, ICH, GAMP, GMP, and ISO standards.

You will oversee CSV, IQ/OQ/PQ, review validation documents, coordinate with QA, support audits, and mentor staff, driving lifecycle documentation, risk assessments, CAPAs, and KPI reporting to sustain validated state across the