Computer System Validation Lead

Overview

Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

Responsibilities

Role Summary

The Computer System Validation Lead will report to the Quality Department. The Computer System Validation Lead at Lupin Coral Springs is responsible for ensuring that computer systems at Lupin Coral Springs Site comply with applicable regulations and standards. This role will work on the development and implementation of procedures, systems, and overall program to support R&D and Commercial operations at Lupin Coral Springs Site. Assist with investigations due to anomalous or OOC results as required.

Essential Duties and Responsibilities

• Develop and maintain the Validation Master Plan (VMP).
• Define and implement validation strategies for computer systems, ensuring compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11).
• Assess the scope of validation efforts based on risk assessments and system criticality.
• Coordinate and oversee Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes.
• Review and approve validation protocols, test scripts, and reports.
• Ensure systems are tested to confirm they meet functional, performance, and security requirements.
• Ensure all validation activities are performed in compliance with applicable regulatory guidelines and quality standards.
• Support audits and inspections by regulatory authorities and clients.
• Maintain documentation to demonstrate compliance, including validation plans, protocols, test results, and summary reports.
• Collaborate with cross-functional teams, including IT, quality assurance, and system users, to ensure successful validation efforts.
• Provide guidance and training to project teams on validation requirements and processes.
• Conduct risk assessments (e.g., Failure Mode Effects Analysis - FMEA) to identify and mitigate potential

Qualifications

Education & Experience

• Bachelor's Degree in computer science, engineering, life science or a related field with relevant experience in this field.
• Minimum of 5 years of pharmaceutical industry experience in or leading CSV activities.
• Familiarity with GxP systems and validation lifecycle
• Understanding of GAMP5 guidelines, FDA 21CFR Part 11 and other applicable regulations.
• Ability to manage multiple projects and priorities
• Excellent communication and interpersonal skills

Lupin  is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

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