Pharma IT Systems Engineer (GxP, CSV)

PHARMIANA LLC

Fort Worth (TX)

On-site

USD 51,000 - 61,000

Full time

3 days ago
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Job summary

PHARMIANA LLC is seeking an experienced Computer Engineer to support IT systems in a pharmaceutical manufacturing environment. You will maintain reliable, secure, and compliant IT and manufacturing systems that support production, quality, and regulatory requirements.

Responsibilities include supporting MES, ERP (SAP), LIMS, and QMS, ensuring compliance with GMP/GxP and FDA 21 CFR Part 11, and participating in CSV activities. On-site duties in Fort Worth, TX are required.

Qualifications

  • Bachelor’s degree in Computer Engineering, Computer Science, IT, or related field.
  • 5–7 years of IT experience, preferably in pharmaceutical or regulated environments.
  • Experience supporting validated systems and regulated applications.
  • Knowledge of GMP, GxP, and FDA compliance concepts.
  • Strong problem-solving and documentation skills.

Responsibilities

  • Support and maintain IT systems used in pharmaceutical manufacturing and quality operations.
  • Provide technical support for systems such as MES, ERP (SAP), LIMS, and QMS.
  • Ensure IT systems comply with GxP, FDA 21 CFR Part 11, and data integrity requirements.
  • Participate in computer system validation (CSV) activities including documentation and testing.
  • Manage servers, networks, databases, and virtualization environments.
  • Implement user access controls, backups, cybersecurity, and disaster recovery.
  • Troubleshoot system issues impacting production or compliance.
  • Work closely with Manufacturing, Quality, and Engineering teams.
  • Support audits and inspections as needed.

Skills

GxP knowledge
Regulated environments
IT literacy
Documentation
Problem solving

Education

Bachelor's degree in Computer Engineering/CS/IT

Tools

MES
SAP ERP
LIMS
QMS

Job description

PHARMIANA LLC is seeking an experienced Computer Engineer to support IT systems in a pharmaceutical manufacturing environment. You will maintain reliable, secure, and compliant IT and manufacturing systems that support production, quality, and regulatory requirements.

Responsibilities include supporting MES, ERP (SAP), LIMS, and QMS, ensuring compliance with GMP/GxP and FDA 21 CFR Part 11, and participating in CSV activities. On-site duties in Fort Worth, TX are required.

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Medical Insurance
401(k) Retirement Plan
Paid Time Off