Pharma IT Systems Engineer – GMP/GxP, CSV Expert

PHARMIANA LLC; Texas; Sur place; USD 51 000 - 61 000; Plein temps

Résumé du poste

PHARMIANA LLC in Texas seeks an experienced Computer Engineer to support IT systems in a pharmaceutical manufacturing environment. The role focuses on maintaining reliable, secure, and compliant IT and manufacturing systems that support production, quality, and regulatory requirements.

The candidate will manage MES, ERP (SAP), LIMS, and QMS, ensure GxP compliance, participate in CSV activities, and collaborate with Manufacturing, Quality, and Engineering teams.

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.

Responsabilités

• 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.

Connaissances

Problem solving

Documentation

Regulatory compliance knowledge

GxP knowledge

Cybersecurity basics

Formation

Bachelor’s degree in Computer Engineering, Computer Science, IT, or related field

Outils

MES

ERP (SAP)

LIMS

QMS

Description du poste

PHARMIANA LLC in Texas seeks an experienced Computer Engineer to support IT systems in a pharmaceutical manufacturing environment. The role focuses on maintaining reliable, secure, and compliant IT and manufacturing systems that support production, quality, and regulatory requirements.

The candidate will manage MES, ERP (SAP), LIMS, and QMS, ensure GxP compliance, participate in CSV activities, and collaborate with Manufacturing, Quality, and Engineering teams.