The role of an IT Systems Specialist in a laboratory setting involves supporting the installation, validation, and maintenance of computerized instrument systems. This requires a deep understanding of IT functionality for analytical equipment to ensure seamless support, upgrades, validation, and maintenance.
Key Responsibilities:
* To gain in-depth knowledge of IT functionalities for laboratory equipment to support various tasks such as installation, upgrades, validations, and maintenance.
* To draft and update IT-related standard operating procedures (SOPs) and other related documents.
* To execute computer system validation deliverables for both new and existing projects in compliance with industry standards.
Requirements and Key Skills:
* Bachelor's degree in Computer Science, Engineering, or a related field is highly preferred, but equivalent industry experience may be considered in lieu of degree.
* Experience working in regulated industries such as pharmaceutical is highly desirable.
* Strong interpersonal skills, effective decision-making abilities, and ability to handle repetitive tasks under time pressure are essential.
* Knowledge of GxP, data integrity, and computer system validation (CSV) principles is necessary.
* Proficiency in Active Directory, identity and access management, and SOP development is also required.