Project Lead- CSV - TechDigital

• Familiarity on Commercial Off Shelf Lab systems,
• Windows Server environment,
• Network experience.

Role Description:

• Provide hands-on end user support, administration, installation, and issue resolution for GxP controlled laboratory equipment, servers, desktops and software packages. Perform laboratory upgrades (software, desktop components, etc…), Create/Review/Approve system documentation and author/execute test scripts as needed.

Role Functions (Functions include, but are not limited to, the following):

• IT Lab Analyst
• Troubleshoot and resolve complex laboratory technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces.
• Perform laboratory equipment, hardware and software upgrades following corporate computer system validation policy and GMP best practices.
• Represent IT on digital strategies within the QC, MS&T and Manufacturing analytical equipment
• Work with Global IT teams on LIMS, Empower, and Mode upgrades/enhancements and issue resolutions.
• Execute routine system administration and maintenance activities as required.
• Create and/or execute software validation scripts to support laboratory.
• Create and maintain system documentation including system design specifications, user requirements, functional requirements or routine controlled application change forms.
• Proactively communicate with laboratory stakeholders and update helpdesk tracking software as necessary.
• Ensure proper user management process is adhered to for all computerized systems
• Administer lab system access requests
• Participates in or leads computerized system software/solution provider audits.
• Ensures systems are in compliance with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, as well as requirements from EU Annex 11 and all Data Integrity standards and guidelines. Ensure applicable standards and specifications are adhered to;
• Work closely with CSV Lead, System Integrator and site team.
• Prepare & complete all System Design Configuration Specification documentation.
• Work with commissioning, qualification and validation (CQV) and site engineering to ensure successful start-up of facility.
• Work with operational readiness team and operations to ensure acceptable turnover.
• Provide support during internal and agency inspections.
• Provide subject matter expert (SME) support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs.

Qualifications & Education:

• A minimum of a bachelor's degree in a technical discipline
• Prior QC Lab experience with analytical instrumentation qualification and system implementation.
• Excellent communication skills (written and oral).
• Ability to multi-task and handle tasks with competing priorities effectively.
• Strong technical aptitude (i.e. able to read and comprehend technical documentation and execute procedures), global regulatory experience and demonstrated experience interfacing with regulators.
• Experience with working in a multinational organization.
• Experience in delivering training to relevant personnel on the correct application of the site quality system procedures.