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Project Lead- CSV
Job in
Rahway, Union County, New Jersey, 07065, USA
Listed on 2026-01-03
Listing for:
TechDigital Group
Full Time
position Listed on 2026-01-03
Job specializations:
-
IT/Tech
IT Support, Technical Support
Job Description & How to Apply Below
Skills:
- Familiarity with Commercial Off Shelf Lab systems
- Experience with Windows Server environment
- Network experience
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.
- 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 policies and GMP best practices.
- Represent IT on digital strategies within QC, MS&T, and Manufacturing analytical equipment.
- Collaborate with Global IT teams on LIMS, Empower, and Mode upgrades/enhancements and issue resolutions.
- Execute routine system administration and maintenance activities.
- Create and/or execute software validation scripts to support laboratory operations.
- 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 processes are followed for all computerized systems.
- Administer lab system access requests.
- Participate in or lead audits of computerized system software/solutions providers.
- Ensure systems comply with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, EU Annex 11, Data Integrity standards, and guidelines.
- Collaborate closely with CSV Lead, System Integrator, and site team.
- Prepare and complete all System Design Configuration Specification documentation.
- Coordinate with CQV and site engineering teams for successful startup of facilities.
- Work with operational readiness teams and operations to ensure smooth turnover.
- Support internal and agency inspections.
- Provide SME support for troubleshooting, problem-solving, and technical guidance to meet business needs.
Education:
- Bachelor's degree in a technical discipline
- Experience with QC Lab analytical instrumentation qualification and system implementation
- Excellent written and oral communication skills
- Ability to multitask and manage competing priorities effectively
- Strong technical aptitude, experience with global regulatory standards, and interfacing with regulators
- Experience working in a multinational organization
- Experience delivering training on site quality system procedures
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