Manager I, Validation

Responsibilities

• Develop, implement, and maintain validation and calibration programs for manufacturing, laboratory, and computerized systems
• Establish and maintain Master Validation Plans (MVPs) to define scope and timing for all validation activities
• Oversee validation activities including IQ/OQ/PQ, method validation, process validation, and computerized system validation (CSV)
• Manage the site calibration program, including asset classification, intervals, and traceability standards
• Review and approve validation protocols, reports, calibration records, and associated documentation
• Manage, mentor, and develop validation and calibration personnel
• Support internal audits, regulatory inspections, and third-party assessments
• Facilitate cross-functional collaboration to ensure successful execution of validation strategies

Requirements

• Bachelor’s degree in a technical, scientific, or engineering discipline
• Minimum 5 years of experience in calibration program management and product/process validation within biotech, medical device, or pharmaceutical industries
• Minimum 2 years of supervisory experience
• Proven experience working with FDA and/or ISO auditors
• Working knowledge of ISO 13485 and 21 CFR Part 11

Preferred Qualifications

• Advanced degree in a relevant scientific or technical field
• Experience with validation and calibration oversight in a regulated bioanalysis environment
• Proficiency with electronic systems such as CMMS, calibration management systems, and document management systems

Benefits

• Medical, dental, and vision coverage with prescription benefits
• 401(k) plan with company matching
• Paid vacation, sick leave, holidays, and parental leave
• Company-paid short-term and long-term disability insurance
• Employee assistance program and various voluntary perks including pet insurance and fitness club contributions

About the Company

Meso Scale Diagnostics (MSD) is a leader in developing advanced technologies for the life sciences industry, focusing on high-sensitivity assays and diagnostic solutions.