Validation Systems Lead — GMP, CSV & QA Oversight

AK America; Town of Harrietstown (NY); On-site; USD 95,000 - 125,000; Full time

Job summary

Bionique Testing Laboratories LLC seeks a Manager for Systems and Equipment Validation to oversee qualification and validation lifecycles for computerized systems, equipment, and utilities in a GMP-regulated setting. The role ensures compliant validation planning, execution, and documentation to meet regulatory expectations.

The candidate will lead validation strategies, review critical validation artifacts, support QA in projects, and maintain master plans and KPIs to drive quality across the

Qualifications

• Bachelor's degree in a scientific/engineering discipline (life sciences, chemistry, engineering).
• 5+ years of QA or validation experience in GMP-regulated environments.
• Strong knowledge of validation principles (CSV, equipment, facilities, utilities).
• Experience authoring and reviewing validation documentation.
• Certification/training in GAMP, risk-based validation, or data integrity is a plus.

Responsibilities

• Lead qualification/validation strategies for computerized systems (CSV), LIMS, lab equipment, and utilities.
• Review/approve validation docs (URS, risk assessments, IQ/OQ/PQ, test scripts, final reports).
• Ensure adherence to internal SOPs and 21 CFR Part 11, Annex 11, GAMP 5.
• Coordinate with QA in cross-functional projects and audits.
• Provide QA oversight during system lifecycle events (upgrades, decommissioning).
• Maintain validation master plans, equipment master lists, and KPI reporting.

Skills

Communication skills

Analytical skills

Organizational skills

GMP knowledge

Education

Bachelor's degree in life sciences/engineering

Tools

LabVantage

ZenQMS

BlueMountain

Veeva

Job description

Bionique Testing Laboratories LLC seeks a Manager for Systems and Equipment Validation to oversee qualification and validation lifecycles for computerized systems, equipment, and utilities in a GMP-regulated setting. The role ensures compliant validation planning, execution, and documentation to meet regulatory expectations.

The candidate will lead validation strategies, review critical validation artifacts, support QA in projects, and maintain master plans and KPIs to drive quality across the