Senior Specialist, Computer System Validation

We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World.

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

Position Summary

The Computer System Validation (CSV) role is responsible for developing, executing, and maintaining validation documentation to ensure IT systems comply with local and global regulatory requirements, quality standards, and Lotte Biologics internal policies. This position partners closely with IT, Quality, Manufacturing, and Engineering teams to support system lifecycle activities, ensure timely completion of quality management system (QMS) actions, and maintain ongoing system compliance within the Information Technology organization.

Duties & Responsibilities

• Create Computer System Validation (CSV) Plans, requirement specifications, and test scripts and coordinate associated activities following Lotte Biologics CSV program.
• Support other IT teams' execution of CSV deliverables such as architecture diagrams, configuration specifications and executing test scripts.
• Provide oversight of routine compliance tasks such as periodic review, user access review, and disaster recovery plans to ensure timely completion of activities.
• Collaborate with other IT functional areas to document robust impact assessments for change controls.
• Independently work with complex issues related to day-to-day activities and escalate issues when necessary.
• Actively participate within IT and others to analyze and address process deficiencies.
• Work collaboratively with others in the Validation, Manufacturing, Manufacturing Engineering, Quality Assurance and Quality Control groups.

• Bachelor's degree in Engineering, Computer Science, Information Systems, or a related technical discipline preferred, OR
  Associate degree with 1-3 years of hands-on experience in computer/software validation within a pharmaceutical, biotech, or other GMP-regulated environment, OR
  Equivalent combination of education and relevant CSV experience.
• Experience and understanding of 21 CFR Part 11, GAMP compliance for computer system (hardware, application software and operating system).

• Proactive, self-starter with good decision-making skills and capable of working alone or in a team environment to develop CSV documentation and to propose mitigations to problems and gaps identified.
• Experience and knowledge in Computer/Software validation (creating validation plans, URS/FRS documents, IQ/OQ/PQ, and validation summary reports)
• Proficiency in written and verbal communication skills with ability to effectively collaborate with technical and senior management staff.
• Experience in data governance, data integrity (DI) assessment, audit trail review, security, user access review, trace matrices, etc. is preferred.
• Ability to work effectively under pressure, handle multiple projects, and meet deadlines.
• Ability to develop and apply new and innovative approaches to projects and processes; a working understanding of lean principles and establishment of effective process metrics is preferred.
• An understanding of deviation and change management for plant manufacturing equipment software is preferred.
• Adhere to policies and procedures (SOPs), training materials and tools to ensure quality standards and regulatory requirements are met.

• This is primarily an office-based position; however, appropriate personal protective equipment (PPE) is required when performing field-based work.
• Frequent, repetitive motions such as keyboarding are required.