GxP Application System Administrator

Hi

My name is Karthik Mutyala from Stark Pharma Solutions Inc we are hiring talents for our client. I am working on GxP Application System Admin position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Role: GxP Application System Administrator

Location: Lexington MA (Hybrid 3 Days Onsite/Week)
Contract Duration: 6 Months (Potential Extension)
Experience: 2 4 Years

Position Overview

We are seeking a GxP Application System Administrator to support and maintain regulated manufacturing laboratory and automation systems within a pharmaceutical/biotech environment. This role will be responsible for system administration user support compliance activities troubleshooting and ensuring systems remain in a validated and compliant state.

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.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions please send me your updated resume along with the best number and time to reach you.

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Email:

15 Corporate Place S Suite 350

Piscataway New Jersey 08854