Systems Analyst III

at  Thermo Fisher Scientific

LOCATION/DIVISION SPECIFIC INFORMATION:

High Point, NC
Softgel Manufacturing
We are seeking a motivated and skilled Mid-Level IT Support Specialist with a validated background in manufacturing, laboratory, and GxP (Good x Practice) compliance. The ideal candidate will provide technical support to our manufacturing and laboratory teams, ensuring the smooth operation of IT systems, equipment, and software while adhering to GxP guidelines. The role requires a proactive problem solver who can collaborate with multi-functional teams to maintain a secure and efficient IT environment.

Responsibilities:

• Provide hands-on technical support to manufacturing staff, addressing hardware, software, and networking issues in a timely manner.
• Collaborate with IT and compliance teams to ensure GxP guidelines are followed, including data integrity, audit trails, and documentation practices.
• Implement and maintain IT solutions in compliance with CFR 21 Part 11 and IEC 62443 standards, ensuring security and data integrity environments.
• Install, configure, and maintain IT equipment, including computers, servers, and specialized laboratory instruments, while ensuring they meet compliance standards.
• Participate in the planning and execution of IT projects related to system upgrades, network improvements, and software implementations within manufacturing and laboratory settings.
• Solve technical issues related to software applications, operating systems, and network connectivity to minimize downtime and disruptions.
• Maintain an accurate inventory of IT assets, including software licenses, hardware components, and peripherals.
• Assist in the creation and maintenance of IT policies, procedures, and documentation, ensuring alignment with GxP regulations, CFR 21 Part 11, and IEC 62443 standards.
• Collaborate with vendors and third-party service providers for equipment maintenance, repairs, and system upgrades.
• Deliver training and support to end-users on IT tools, applications, security practices, and compliance requirements to enhance overall system knowledge and awareness.
• Stay updated with industry trends, standard methodologies, and regulatory changes related to IT, manufacturing, laboratory, GxP environments, CFR 21 Part 11, and IEC 62443.

Qualifications:

• Bachelor’s degree in Information Technology, Computer Science, or equivalent work experience.
• Minimum 3 years of experience in IT support role within manufacturing, laboratory, or other regulated environments.
• Solid understanding of GxP regulations (GMP, GLP, GCP), CFR 21 Part 11, and IEC 62443 standards, and experience implementing IT solutions in compliance with these guidelines.
• Proficiency in solving hardware and software issues on Windows and/or macOS platforms.
• Experience with networking concepts, protocols, and configurations.
• Familiarity with laboratory instruments and software commonly used in scientific research and data analysis.
• Superb communication and social skills to effectively collaborate with multi-functional teams and end-users.
• Ability to adapt to evolving technologies and work in a dynamic, fast-paced environment.

Join our team and contribute to the success of our manufacturing and laboratory operations by ensuring reliable IT support and alignment to GxP standards, CFR 21 Part 11, and IEC 62443. If you are a dedicated IT professional with a passion for compliance and technical problem-solving, we encourage you to apply.

• Provide hands-on technical support to manufacturing staff, addressing hardware, software, and networking issues in a timely manner.
• Collaborate with IT and compliance teams to ensure GxP guidelines are followed, including data integrity, audit trails, and documentation practices.
• Implement and maintain IT solutions in compliance with CFR 21 Part 11 and IEC 62443 standards, ensuring security and data integrity environments.
• Install, configure, and maintain IT equipment, including computers, servers, and specialized laboratory instruments, while ensuring they meet compliance standards.
• Participate in the planning and execution of IT projects related to system upgrades, network improvements, and software implementations within manufacturing and laboratory settings.
• Solve technical issues related to software applications, operating systems, and network connectivity to minimize downtime and disruptions.
• Maintain an accurate inventory of IT assets, including software licenses, hardware components, and peripherals.
• Assist in the creation and maintenance of IT policies, procedures, and documentation, ensuring alignment with GxP regulations, CFR 21 Part 11, and IEC 62443 standards.
• Collaborate with vendors and third-party service providers for equipment maintenance, repairs, and system upgrades.
• Deliver training and support to end-users on IT tools, applications, security practices, and compliance requirements to enhance overall system knowledge and awareness.
• Stay updated with industry trends, standard methodologies, and regulatory changes related to IT, manufacturing, laboratory, GxP environments, CFR 21 Part 11, and IEC 62443