Computer Systems Validation Consultant

About the Company

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.

About the Role

The Computer Validation Specialist will ensure computerized systems are in full compliance with regulatory requirements, company policies, and procedures. The role will contribute to the development, execution and review of validation deliverables for computer systems, hardware and software to ensure systems are implemented according to regulatory requirements and are maintained in an ongoing state of quality and control. This role will be hired through a third-party partner.

Responsibilities

• Prepare, review, and approve various computer validation documents for CSV projects including the following
• Regulatory Assessment for determination of GxP and Part 11 relevance
• Validation Plan
• Technical Documentation (e.g., User Requirement, Functional Requirements, Design Specifications)
• Requirements Traceability Matrix
• Risk Assessment
• IQ/OQ/PQ Protocols, test scripts and Reports
• Validation Summary Report
• Review existing validation documentation for the computerized systems used in laboratory and manufacturing floor and retrospectively validate systems as needed.
• System integration and validation testing for new/enhanced web applications.
• Testing of data integrations with Trackwise, Empower, SAP and other systems.
• Perform pre and post review and approval of validation test scripts including test defects.
• Interface effectively with management personnel in IT, Engineering, Quality, R&D, and other technical disciplines.
• Provides management with updates on projects, and when necessary, communicates risk-based issue.
• Provides value-added guidance during the design, deployment, maintenance, and retirement of IT computer system. This guidance applies to all systems developed in house, developed by contractors, and off the shelf (OTS) software. May perform supplemental research to provide options for compliant solutions to barriers encountered during validation.
• Reviews and approves software validation documentation to ensure documentation is compliant with CSV procedures and all applicable quality system regulations.
• Exercises judgment in selecting methods and language to provide compliant solutions to address and document issues, which may arise during validation.
• Ensures that the system’s validation state is maintained throughout the system life cycle.
• Ensure a high degree of Inspection Readiness for Systems in CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibility.
• Performs a periodic review of systems to monitor the validation status of the system.
• Other duties as assigned.

Qualifications

• E DUCATION & E XPERIENCE
• Minimum of 4 years System Development Life Cycle experience, including system integration and validation testing
• Software quality assurance
• Experience in manual testing
• Experience in the Life Sciences industry
• Knowledge of FDA regulatory requirements, including 21 CFR Parts 11
• Strong understanding of IT network infrastructure and required qualification
• Excellent communication (oral and written) and organizational skills
• Ability to work independently and in a team setting
• Test Automation Tools
• Experience validating laboratory systems, PLCs and/or SAP is a plus

Required Skills

• System Development Life Cycle experience, including system integration and validation testing
• Software quality assurance
• Manual testing
• Knowledge of FDA regulatory requirements, including 21 CFR Parts 11
• Strong understanding of IT network infrastructure and required qualification
• Excellent communication (oral and written) and organizational skills
• Ability to work independently and in a team setting
• Test Automation Tools

Preferred Skills

• Experience in the Life Sciences industry
• Experience validating laboratory systems, PLCs and/or SAP

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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