GxP Lab Systems IT Specialist

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

***Hybrid in Camarillo, CA***

We are seeking an experienced GxP Lab Systems IT Specialist to support IT operations within a working GMP laboratory environment in Camarillo, CA. This is a hands-on role requiring coordination across Quality, Validation, and IT teams, ensuring seamless management of 20+ laboratory systems while maintaining strict GxP compliance.

Primary Responsibilities

• System Support & Oversight
• Maintain and support a suite of ~2 dozen lab systems, including:
• 3 Enterprise Systems
• 7+ Standalone Lab Systems
• Oversee day-to-day operations for critical lab equipment 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 all IT systems supporting laboratory operations are GxP compliant
• Maintain validation documentation, user requirements, and audit trails
• Work with Validation and QA teams on change control and periodic review processes
• Serve as the primary IT liaison between Business, Quality Assurance (QA), and Validation
• Support business users and SMEs with system access, troubleshooting, and lifecycle planning
• Assist in implementation, upgrade, and migration projects involving lab systems
• Lead or coordinate validation activities including IQ/OQ/PQ
• Apply prior experience leading GxP system support or deployment
• Support equipment interfacing and data integrity measures
• Ensure alignment with 21 CFR Part 11 and ALCOA+ principles
  

Additional Responsibilities

• Performs other related duties and assignments as required
  
  

Qualifications

• 5+ years supporting GxP laboratory systems in a GMP environment
• Proven track record with lab equipment and software such as Chromeleon, Jasco, CE, and 32 Karat
• Strong experience with enterprise lab informatics and standalone software platforms
• Prior lead experience or technical ownership of regulated system portfolios
• Hands-on support of EPV, WindLab integration, LabX, and other lab software highly preferred
• Excellent knowledge of GAMP 5, 21 CFR Part 11, and FDA compliance
• Ability to manage multiple systems and interface with cross-functional teams
• Strong documentation and communication skills
• Background in Biotech or Pharmaceutical labs
• Previous experience with system audits or inspection readiness
• Familiarity with data integrity audit trail review tools
  
  

Education & Certifications

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

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
  
  

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 65.00 - 75.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers