GxP Application System Administrator

Key Responsibilities

• Administer and support GxP-regulated computerized systems across manufacturing, laboratory, and automation environments.
• Manage user accounts, system access, permissions, and security controls.
• Perform system maintenance, monitoring, troubleshooting, backups, and routine health checks.
• Support periodic system reviews, audits, inspections, and compliance activities.
• Maintain system administration records, logs, and documentation.
• Participate in change control, deviation investigations, and CAPA activities.
• Ensure compliance with data integrity principles, CSV requirements, and regulatory standards.
• Collaborate with Quality, Manufacturing, IT, Validation, and Engineering teams to support business operations.

Required Qualifications

• 2+ years of experience administering GxP-regulated computerized systems in pharmaceutical, biotech, or life sciences environments.
• Experience supporting manufacturing, laboratory, or automation applications.
• Working knowledge of: DCS/SCADA Systems (DeltaV, FactoryTalk, Metasys), Historian Systems (PI), Laboratory Systems (LabX, Unicorn, Sartocheck, Nova Biomass, ThinManager).
• Understanding of: Data Integrity (ALCOA+), Computerized System Validation (CSV), Change Control & CAPA Processes (TrackWise).
• Strong troubleshooting, documentation, and communication skills.

Pay

Pay details are not specified in the job posting.

Schedule

The schedule is described as Hybrid 3 Days Onsite/Week for the contract duration of 6+ Months (Potential Extension).

Benefits

Benefits details are not specified in the job posting.

Contact

If you are interested in this position, please send your updated resume to karthik@starkpharma.com.