Manager I, Validation

POSITION SUMMARY:

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.

DUTIES AND 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.

EXPERIENCE AND QUALIFICATIONS

• Bachelor's degree in a technical, scientific, engineering, or technical discipline; advanced degree preferred.
• 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.
• Experience with validation and calibration oversight in a regulated bioanalysis environment is preferred.

KNOWLEDGE, SKILLS AND ABILITIES

• 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

PHYSICAL DEMANDS

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

WORK ENVIRONMENT

• Standard office environment.
• Limited travel required.

COMPENSATION SUMMARY

The annual base salary for this position ranges from $101,400 to $154,650. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

BENEFITS SUMMARY

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO STATEMENT

MSD is an Equal Opportunity Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO statement, please visit here. Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.