GxP Lab Systems Engineer

BioSpace; South Brunswick (NJ); Hybrid; USD 70,000 - 105,000; Full time

Benefits offered by this job

Bonus eligible

Medical, dental, vision, Rx insurance

401K with match

Job summary

Tris Pharma, Inc. is seeking a motivated Lab Systems Administrator to join the Information Technology team in Monmouth Junction, NJ.

This role is ideal for a professional with minimum 2 years experience administering and supporting laboratory computerized systems in a GxP regulated environment. The candidate will manage day-to-day system administration, implementation and support of Lab Systems and applications for QC, Method Validation and R&D, working closely with analysts, instrument vendors

Qualifications

• Bachelor’s Degree in a technical field (i.e., Science, Engineering, IT) and minimum 2 years relevant GxP lab systems experience.
• Excellent understanding of GAMP 5, 21 CFR Part 11, Computer System Validation, and Quality Management System principles.
• Excellent collaboration and communication skills, both written and verbal.
• Ability to manage competing priorities and flexibility to shift workload when needed.
• Working knowledge of Microsoft Office applications.
• A team player with ability to work with people at all levels.

Responsibilities

• Lab Systems Administration and Support across Waters Empower, Waters NuGenesis, Agilent OpenLab and bench-top instruments.
• Collaborate with analysts, instrument vendors and IT to ensure controlled, compliant lab systems.
• Support system implementations, upgrades, IQ/OQ/PQ validation and IT policy adherence.
• Maintain data integrity and support audits from IT and regulatory teams.

Skills

GxP compliance

Regulatory knowledge

Communication skills

Prioritization

MS Office

Education

Bachelor’s Degree in a technical field

Tools

Waters Empower

Waters NuGenesis

Agilent OpenLab

bench-top instruments

Job description

Tris Pharma, Inc. is seeking a motivated Lab Systems Administrator to join the Information Technology team in Monmouth Junction, NJ.

This role is ideal for a professional with minimum 2 years experience administering and supporting laboratory computerized systems in a GxP regulated environment. The candidate will manage day-to-day system administration, implementation and support of Lab Systems and applications for QC, Method Validation and R&D, working closely with analysts, instrument vendors