CSV Engineer - Rensselaer, United States - Katalyst Healthcares and Life Sciences

Description

• Oversee the validation and maintenance of computer systems used in the laboratory, ensuring compliance with regulatory requirements, including FDA regulations, GxP guidelines, and industry standards.
• Develop and execute validation protocols for laboratory computer systems, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Collaborate with laboratory staff, IT personnel, and quality assurance teams to ensure the proper installation, configuration, and validation of laboratory software applications and hardware.
• Manage and maintain user access controls and permissions for laboratory computer systems, ensuring data integrity and confidentiality.
• Perform periodic reviews and assessments of laboratory computer systems to identify and address any compliance gaps or issues.
• Coordinate and support internal and external audits and inspections related to laboratory computer systems and data integrity.
• Provide training and support to laboratory personnel on the use and maintenance of validated computer systems.
• Stay updated with current industry regulations, guidelines, and technological advancements related to computer systems validation and laboratory IT administration.
• Collaborate with cross-functional teams to identify opportunities for process improvement and implement best practices in laboratory IT administration.
• Maintain accurate documentation, including validation protocols, reports, standard operating procedures (SOPs), and change control documentation.

• Bachelor's degree in a relevant scientific or technical field, such as Computer Science, Information Technology, or a related discipline.
• Minimum of 4 years of experience in computer systems validation and IT administration within the pharmaceutical industry, with a focus on laboratory systems.
• Strong knowledge of FDA regulations, GxP guidelines, and other relevant regulatory requirements pertaining to computer systems validation and data integrity.
• Experience in developing and executing validation protocols for laboratory computer systems, including IQ, OQ, and PQ.
• Familiarity with laboratory software applications commonly used in the pharmaceutical industry, such as LIMS, chromatography data systems, and electronic laboratory notebooks.
• Proficient in managing user access controls and permissions for laboratory computer systems.
• Strong understanding of data integrity principles and best practices in laboratory IT administration.
• Excellent analytical and problem-solving skills, with the ability to troubleshoot technical issues and provide effective solutions.
• Detail-oriented and able to manage multiple projects and priorities simultaneously.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.