Senior Specialist, Computer System Validation

Position Summary

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.

Education & Experience

• 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).

Knowledge, Skills, Abilities

• 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.

Physical Demands

Work Environment

This position is based indoors, and the employee will primarily be working with others, but also independently. This position requires personnel presence on site, 50-100% of the time. This position is a team and project-based position that may require occasional shift work, weekends, and holidays.

Target Bonus

8%

Work Location:

East Syracuse, NY