CSV Validation Specialist (expert within GXP Lab settings)

Fully remote contract position (6 months with options to extend or convert to full-time) for candidates in the Eastern Time Zone.

About us

A leading lab-system company at the forefront of computer systems validation (CSV) is seeking a CSV Specialist or Senior CSV Specialist. Preference is given to candidates in the Northeast, though Central Time Zone candidates with relevant experience will be considered.

Responsibilities

• Follow established SDLC (System Development Life Cycle) and Change Control procedures.
• Assess the intended use of new applications, interfaces, and embedded instrument software for GxP and 21 CFR Part 11 requirements.
• Participate in vendor assessments for adherence to applicable standards and guidelines, including ISO 9001/13485, ISO 27001, and GAMP 5.
• Ensure that applicable 21 CFR Part 11 features, including electronic signatures and audit trails, are enabled in relevant applications for the accurate handling of GxP records.
• Serve as a subject matter expert for internal stakeholders regarding GxP and CSV requirements.
• Create and execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and regression testing, leveraging vendor processes and documentation where appropriate.
• Perform periodic compliance reviews for systems.
• Work with IT and laboratory stakeholders to ensure regulatory requirements for software and instruments are appropriately addressed and tested.
• Assist customers with IT questionnaires and site audits, where applicable.
• Maintain knowledge of current regulatory guidance, industry standards, and best practices.
• Perform other job duties as assigned.

Qualifications

• Expert-level Director/Program Management experience within CSV GxP settings or adjacent environments.
• Strong analytical and problem-solving skills.
• Ability to organize and prioritize multiple, overlapping tasks.
• Strong customer service skills.
• Strong oral and written communication skills.
• Ability to take initiative with limited oversight and guidance.

Pay

$55 - $75 per hour