Project Lead- CSV

TechDigital Group; Rahway (NJ); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a skilled IT Lab Analyst to provide comprehensive support for laboratory systems. This role involves troubleshooting complex technical issues, performing upgrades, and ensuring compliance with regulatory standards. The ideal candidate will have a strong technical background, excellent communication skills, and the ability to manage multiple priorities in a fast-paced environment. Join a dynamic team dedicated to advancing laboratory operations and ensuring the highest quality standards in a multinational setting.

Qualifications

• Experience with QC Lab analytical instrumentation qualification and system implementation.
• Strong technical aptitude and experience with global regulatory standards.

Responsibilities

• Provide hands-on end-user support and resolve complex laboratory technical issues.
• Collaborate with Global IT teams on upgrades/enhancements and issue resolutions.

Skills

Commercial Off Shelf Lab systems

Windows Server environment

Network experience

Technical support

GxP compliance

Education

Bachelor's degree in a technical discipline

Tools

LIMS

Empower

Job description

Primary & Secondary Skills:

• Familiarity with Commercial Off Shelf Lab systems
• Experience with 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):

• 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.

Qualifications & 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