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.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com