Lab Systems Administrator

Tris Pharma Inc•South Brunswick, NJ

just now•$70,000 - $105,000•Hybrid

About The Position

Tris Pharma, Inc. is a leading privately-owned US biopharmaceutical company focused on developing and commercializing innovative medicines. They are seeking a motivated Lab Systems Administrator to join their Information Technology team in Monmouth Junction, NJ. This role is ideal for a professional with a minimum of 2 years of experience administering and supporting laboratory computerized systems in a GxP regulated environment. The candidate will manage the day-to-day system administration, implementation, and support of Lab Systems and applications for Quality Control, Method Validation, and R&D, working closely with analysts, instrument vendors, and IT team members to ensure systems are compliant, reliable, and available. This role requires knowledge of Waters Empower, Waters NuGenesis, Agilent OpenLab, various bench-top instruments, GAMP 5, 21 CFR Part 11, and Computer System Validation principles to deliver governed and inspection-ready laboratory systems.

Requirements

Bachelor’s Degree in a technical field (i.e., Science, Engineering, Computer Science, IT or related field)
Minimum 2 years relevant experience administering and supporting laboratory or computerized GxP systems experience in the pharmaceutical, biotechnology or other related highly regulated lab environment.
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 the ability to work with people at all levels and diverse skill sets.

Nice To Haves

Hands-on experience with Waters Empower, Waters NuGenesis, Agilent OpenLab, and various bench-top instruments (Malvern instruments, GCMS, FTIR, Density Meters, etc.).
Understanding of IT infrastructure related to Lab system (network) connectivity and security.
Understanding of the interdependency between hardware and software/applications of Lab systems.

Responsibilities

Manage Lab applications and systems including, but not limited to: Waters Empower, Waters NuGenesis, Agilent OpenLab, and various bench-top instruments (Malvern instruments, GCMS, FTIR, UV-VIS, Density Meters, etc.)
Collaborate with lab analysts and managers, instrument vendors, and other IT team members to implement, administer, and support GxP applications and systems in a controlled laboratory environment
Support new system implementations and upgrades, assisting with design or configuration and validation (IQ/OQ/PQ) to ensure solutions meet business needs while adhering to IT policies, compliance standards, and GxP requirements, coordinating with vendors and escalating to management as needed
Maintain the GxP Systems Inventory and User Access Management, creating and maintaining roles and privileges, including activation and/or deactivation of users
Support configuration management of validated systems, escalating changes to management for review and approval as needed
Develop a strong understanding of Data Management and Data Integrity requirements as they relate to FDA regulations
Perform data backup and restore procedures, including full system backups and restores of validated systems
Support and guide data archiving processes to ensure archived data remains complete and retrievable
Recover GxP systems when required and perform any other related activity assigned by IT Management, applying cGMP principles and following internal SOPs, work instructions (WIs), and regulatory requirements
Conduct Periodic Reviews such as User Access Management, Systems Validation Reviews, and SOP Reviews to confirm computerized systems remain compliant with company procedures and regulatory agency requirements
Assist with QMS processes within IT, especially change control impact assessments for GxP system changes, performing Root Cause Analysis and executing CAPAs
Help identify opportunities to improve system usage, minimize manual effort and interventions where possible, and enable data integrations, escalating recommendations to management as needed
Suggest alternate processes, procedures, and process automation pathways to streamline and increase the effectiveness and efficiency of IT operations, escalating proposals to management for consideration
Collaborate with various stakeholders and support the implementation of best practices, escalating to management as needed
Support regulatory, customer, and other such audits from the IT department