GxP Lab Systems IT Specialist

Job Title: GxP Lab Systems IT Specialist Location: Camarillo, CA (Hybrid) Job Type: Full-Time | Contract

Position Overview

We are seeking a highly skilled and experienced GxP Lab Systems IT Specialist to support IT operations within a working GMP laboratory environment located in Camarillo, California . This role is hybrid and requires hands-on expertise in managing and supporting regulated laboratory systems. The ideal candidate will possess a strong background in GxP compliance, laboratory informatics, and validation activities, and will serve as the key liaison between Quality Assurance, IT, and laboratory staff.

Primary Responsibilities

System Support & Oversight

Maintain and support approximately 20+ lab systems , including:

3 Enterprise Systems

7+ Standalone Lab Systems

Oversee day-to-day IT operations for key laboratory systems and software such as:

HPLCs

Chromeleon CDS

Capillary Electrophoresis (CE)

32 Karat Software

EPV systems integrated with WindLab

LabX and Software X Pro

GxP Compliance & Documentation

Ensure that all IT systems supporting lab operations remain GxP compliant

Maintain and manage:

Validation documentation

User requirements

Audit trails

Collaborate with QA and Validation teams on:

Change control processes

Periodic system reviews

Lead or support validation activities including:

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Support lifecycle planning, system upgrades, and data integrity efforts

Ensure compliance with 21 CFR Part 11 , ALCOA+ principles , and GAMP 5

Stakeholder Support

Act as the primary IT liaison for Business, Quality Assurance (QA), and Validation teams

Provide support to business users and SMEs for access issues and troubleshooting

Lead system implementation and migration projects

Interface with equipment and ensure data integrity across platforms

Additional Responsibilities

Perform other duties as assigned to support laboratory operations and compliance initiatives

Required Qualifications

5+ years of experience supporting GxP laboratory systems in a GMP-regulated environment

Strong technical knowledge of lab equipment and software such as:

Chromeleon

Jasco

Capillary Electrophoresis (CE)

32 Karat Software

Experience with both enterprise lab informatics and standalone lab platforms

Demonstrated ability to lead or provide technical ownership over regulated IT systems

Hands-on experience with EPV, WindLab, LabX, and similar lab software highly desirable

Deep understanding of:

GAMP 5

21 CFR Part 11

FDA and global compliance standards

Experience preparing for and supporting audits and inspection readiness

Strong documentation and communication skills

Background in Biotech or Pharmaceutical laboratory settings

Familiarity with data integrity tools and audit trail review processes

Education & Certifications

Bachelor’s Degree in Life Sciences, Engineering, Computer Science, Quality Assurance, or a related field is required

Working Conditions

Hybrid work schedule: combination of onsite presence in Camarillo, CA and remote work

Prolonged periods of sitting or standing while working on a computer

Frequent use of standard office equipment such as a computer, scanner, printer, and phone

Regular communication with cross-functional teams via phone, email, and messaging platforms