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Role Overview

This senior validation leadership role is focused on overseeing the full qualification and validation program for equipment, facilities, utilities, and computerized systems in a regulated manufacturing environment. The position requires strong ownership of compliance, documentation, cross-functional coordination, and continuous improvement across quality systems.

Key Responsibilities

Direct the end-to-end validation lifecycle using the V-model, starting from user requirements and technical assessment through FAT, SAT, IQ, OQ, PQ, and periodic requalification.
Ensure utilities such as purified water, water for injection, compressed gases, and nitrogen remain in a qualified state, and that cleanroom qualifications continue to meet ISO 14644 standards.
Oversee calibration planning, including the basis for calibration rationale, setting acceptance criteria, determining intervals, and managing outsourced calibration work.
Lead computerized system validation for quality control, manufacturing, and utility-related applications, ensuring new critical systems are aligned with 21 CFR Part 11 expectations.
Assign and coordinate work across validation subject-matter experts to support qualification and validation execution.
Manage quality system activities such as change control, deviation investigations, CAPA, and audit support, while providing technical input on validation matters.
Work closely with cross-functional teams to monitor product lifecycle status and support compliance with country-specific registration requirements.
Maintain control of validation records, including archiving, retrieval, and document distribution.
Drive improvement and risk management initiatives, identify compliance gaps, and recommend structured corrective actions.
Embed data integrity principles such as ALCOA+ across quality-related systems and processes.
Support product life cycle validation activities including process validation, product remediation, sterilization validation, cleaning validation, gowning qualification, visual inspection, aseptic process simulation, and transport validation.
Follow ISO 14001:2015 environmental management expectations and site HSE policies in day-to-day operations.
Reduce environmental impact, maintain safe working practices, manage waste appropriately, use equipment safely, and report hazards or non-conformities when identified.

Competencies Expected

Strong results orientation with clear accountability and ownership.
High level of compliance discipline, initiative, flexibility, and attention to detail.
Excellent communication, stakeholder management, and collaboration abilities.
Proven leadership and people management capability.
Strong planning, prioritization, organization, and adaptability skills.
Ability to identify, reduce, and prevent environmental and operational risks.
Active contribution to EHS activities, audits, and continual improvement efforts.

Qualifications and Functional Knowledge

Bachelor’s degree in engineering (Mechanical, Electrical, or Mechatronic) or a pharmacy/science background with a master’s qualification in science or pharmacy.
10 to 15 years of experience in qualification and validation.
Good working knowledge of GMP, GDP, ISO 9001, and ISO 14001 requirements.
Exposure to regulatory expectations from agencies and frameworks such as FDA, WHO, and EU.
Hands-on experience with audits, CAPA, risk management, and QMS environments.
Strong leadership, team management, analytical thinking, and problem-solving abilities.
Proficiency in MS Office and electronic QMS platforms.

Additional Information

This role also requires strong document governance for validation records and a practical understanding of environmental, health, and safety responsibilities within a manufacturing site.

Sr. Manager-MSAT (Validation)

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