Job Title: Lab IT & CSV Professional
Main Purpose and Objectives of Position:
The Lab IT & CSV Professional is a key member of the site IT & CSV team, responsible for installing, validating, and maintaining various computerized instrument systems in laboratory and manufacturing areas. This role ensures that these systems meet all cybersecurity, data integrity, life cycle management, and quality requirements.
* Develops in-depth knowledge of IT functionality of relevant lab equipment to aid installation, upgrade, and maintenance activities.
* Provides technical oversight for computerized instrument validation (CSV) processes, adhering to site and corporate procedures and GMP guidelines.
* Manages, coordinates, develops, and executes computer system validation deliverables for new and existing projects.
* Liaises with vendors to design and deploy computerized instrument solutions integrating with existing onsite IT services and infrastructure.
* Ensures timely delivery of new instrument installations and software upgrades.
* Leads computerized instrument upgrades and improvement projects, promoting solutions to business problems.
* Resolves system problems using data analysis and problem-solving skills.
* Participates in and supports audit activities.
* Represents the site and shares knowledge at corporate forums.
Required Skills:
* Extensive knowledge and experience in development and execution of Computer System Validations, particularly in the laboratory systems area.
* Experience in administration of computerized lab equipment.
* Demonstrated troubleshooting ability, understanding of lab equipment software.
* Extensive understanding of regulatory requirements associated with CSV, including ER/ES (21 CFR Part 11), security, and data integrity.
* Demonstrated initiative to build relationships, learn new business processes, and identify opportunities.
* Strong leadership and influencing skills and ability to work in cross-functional team environments.
* Strong analytical and problem-solving skills are required.
* Strong written and verbal communication skills are required.
Desired Skills:
* Knowledge of IT infrastructure platforms and ISA S95 architecture.
* Knowledge of Industry 4.0.
* Project management experience.
* Knowledge of lab execution and LIMS systems.
* Familiarity with Agile methodologies.
Educational Requirements:
BS in Computer Science, Engineering, or related field. Comparable industry experience will also be considered.