Manager I, Validation

MESO SCALE DIAGNOSTICS, LLC.•Gaithersburg, MD

5h•Onsite

About The Position

The Manager I, Validation, is responsible for the development, implementation, and continuous improvement of the validation and calibration programs in compliance with applicable regulatory and quality standards to maintain audit readiness, ensure alignment with internal quality systems, and support regulatory compliance. This role is also responsible for providing leadership and oversight for validation and calibration activities across facilities, utilities, equipment, computerized systems, test methods, and laboratory and manufacturing processes, and ensures that risk-based validation strategies are defined and executed throughout the product/process lifecycle.

Requirements

Bachelor’s degree in a technical, scientific, engineering, or technical discipline
Minimum five (5) years of experience in calibration program management, product, and process validation within the biotech, medical device, in vitro diagnostics, or pharmaceutical industries.
Experience working with FDA and/or ISO auditors is required.
Minimum two (2) years’ supervisory experience required.
Strong leadership and team development capabilities.
Strong validation fundamentals and analytical background.
Experience with electronic systems such as CMMS, calibration management systems, and document management systems.
Working knowledge of calibration standards and practices, including traceability and measurement uncertainty principles.
Familiarity with applicable regulations and standards, including ISO 13485, ISO 9001, ISO/IEC 17025, Good Clinical Practice, 21 CFR Part 58 and 21 CFR Part 11.
Excellent oral, written communication, and interpersonal skills.
Proficiency in Microsoft Office
Familiarity with tools such as Visio, ERP systems, and project management software.
A wide degree of creativity and latitude is expected, including the ability to multitask and work productively in a demanding environment with changing priorities

Nice To Haves

Advanced degree preferred.
Experience with validation and calibration oversight in a regulated bioanalysis environment is preferred.

Responsibilities

Develop, implement, and maintain MSD’s validation and calibration programs for manufacturing operations, laboratory services, facilities, equipment, and computerized systems.
Implement and maintain risk management practices to support validation and calibration decision-making.
Establish and maintain Master Validation Plans (MVPs) for all manufacturing facilities, equipment, and processes to define the scope and drive the timing of validation activities.
Provide subject matter expertise for new equipment, systems, product introductions, and facility expansions.
Manage validation and calibration schedules to ensure timely execution.
Oversee validation activities including IQ/OQ/PQ, method validation, process validation, and computerized system validation (CSV).
Review and approve validation protocols, reports, calibration records, and associated documentation.
Manage the site calibration program, including asset classification, calibration intervals, traceability standards, and compliance requirements.
Ensure timely investigation and resolution of calibration out-of-tolerance (OOT) events and validation deviations.
Maintain procedures, templates, and standards for validation and calibration in alignment with the Quality Management System.
Support design control activities by ensuring validation requirements are incorporated into product and process development.
Manage, mentor, and develop validation and calibration personnel.
Allocate resources and prioritize activities to meet organizational goals
Provide validation expertise to project teams supporting new equipment, systems, and facility expansions.
Facilitate cross-functional collaboration with various departments to develop validation strategies and ensure successful execution of validation and calibration activities.
Review and approve change orders, deviations, nonconformances, CAPAs, and impact assessments affecting validated or calibrated systems.
Support internal audits, regulatory inspections, and third-party assessments.
Promote a culture of quality, compliance, and continuous improvement.
Specific duties may vary depending upon departmental requirements.