Senior Validation Lead - Systems & Equipment (GMP/CSV)

Asahi Kasei; 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 the qualification and validation lifecycle for computerized systems, equipment, utilities, and related processes to ensure compliance with FDA, EMA, ICH, GAMP, GMP, and ISO.

This role plans, executes, and documents validation activities, supervises staff, and collaborates with QA and other departments to maintain quality standards across system lifecycles.

Qualifications

• Bachelor's degree in a scientific/engineering discipline.
• 5+ years of QA or validation experience in GMP environments.
• Experience authoring and reviewing validation documentation.

Responsibilities

• Oversee qualification/validation strategies for CSV, laboratory systems, equipment and utilities.
• Coordinate QA support, change control, deviations, and CAPAs.
• Support audits and maintain regulatory compliance for validation activities.
• Lead and coach team members; collaborate with internal departments and external vendors.
• Maintain validation master plans, equipment master lists, and KPI reporting.

Education

Bachelor's degree in scientific/engineering discipline

Excellent communication, analytical, and organizational skills

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 the qualification and validation lifecycle for computerized systems, equipment, utilities, and related processes to ensure compliance with FDA, EMA, ICH, GAMP, GMP, and ISO.

This role plans, executes, and documents validation activities, supervises staff, and collaborates with QA and other departments to maintain quality standards across system lifecycles.