GxP Application System Administrator

Stark Pharma Solutions Inc; Lexington (MA); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc in Lexington, MA is seeking a GxP Application System Administrator to support regulated manufacturing, laboratory and automation systems, ensuring validation and compliance.

The role covers system administration, user support, change control, CAPA, data integrity (ALCOA+), and collaboration with Quality, Manufacturing, IT and Validation teams.

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 data integrity (ALCOA+) and CSV validation; familiarity with TrackWise change control and CAPA processes.

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.

Skills

GxP-regulated systems

CSV validation

Change Control

CAPA processes

DCS/SCADA

PI Historian

LabX/Unicorn

ALCOA+ data integrity

Troubleshooting

Documentation

Education

Tools

DeltaV

FactoryTalk

Metasys

PI historian

LabX

Unicorn

Sartocheck

Nova Biomass

ThinManager

TrackWise

Job description

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.

Recruiting Manager

Stark Pharma Solutions Inc

Email: [e-mail]

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com