Validation Operations Coordinator

Responsibilities

• Coordinate the validation documentation lifecycle, including plans, protocols, reports, deviations, and change control records.
• Format, route, and track validation documents through review and approval workflows in accordance with SOPs.
• Maintain organized validation documentation files within electronic document management systems (EDMS).
• Coordinate execution schedules for validation activities such as IQ, OQ, PQ, revalidations, and periodic reviews.
• Maintain validation trackers, logs, and dashboards to monitor deliverables and milestones.
• Serve as a coordination point between Validation, Engineering, Automation/IT, QA, and Manufacturing.
• Support inspection and audit readiness by providing document retrieval and status tracking during internal and regulatory audits.
• Assist with tracking the status and documentation requirements for change controls, deviations, and CAPAs.

Requirements

• Bachelor’s degree in Science, Engineering, Computer Science, or a related field.
• Understanding of the validation lifecycle and concepts (IQ/OQ/PQ).
• Familiarity with GMP documentation practices and data integrity principles.
• Experience with EDMS, QMS, or validation tracking tools.
• Strong attention to detail and organizational skills.
• Ability to manage multiple priorities and deadlines in a regulated environment.

Preferred Qualifications

• Experience working in a regulated pharmaceutical, biotech, or medical device environment.
• Previous experience supporting technical, validation, or quality teams.

About the Company

Tolmar is a pharmaceutical company dedicated to improving patient well-being through high-quality products and ethical business practices. We foster a culture of proactive engagement, continuous improvement, and accountability.