Computer System Validation (CSV) Contractor

United Pharma; Indiana; On-site; USD 83,000 - 124,000; Part time

Job summary

United Pharma seeks a hands-on Computer System Validation (CSV) Contractor to support a pharmaceutical client with validation activities, software lifecycle management, and qualification of analytical laboratory equipment.

The ideal candidate has experience in regulated environments, ensuring GxP compliance and alignment with SOPs and regulatory standards. You will document changes, coordinate TrackWise Change Controls, and use KNEAT for validation documentation.

Qualifications

• Hands-on CSV experience in the pharmaceutical industry.
• Knowledge of GxP compliance and regulatory standards.
• Experience qualifying analytical laboratory instruments (LC, MS, GC, UPLC, ICP, pH meters).

Responsibilities

• Execute and manage CSV activities per regulatory requirements and SOPs.
• Support software validation for new implementations and updates.
• Coordinate Change Controls using TrackWise and document validation records.

Skills

Computer System Validation

GxP compliance

Analytical instrument qualification

Documentation & records

Cross-functional collaboration

Regulatory standards

Software lifecycle management

Change Controls

Onsite equipment setup

Tools

TrackWise

KNEAT

Analytical instruments (LC/MS/GC/UPLC/ICP/pH meters)

Job description

Seeking a hands-on Computer System Validation (CSV) Contractor to support a pharmaceutical client with validation activities, software lifecycle management, and qualification of analytical laboratory equipment. The ideal candidate will have experience working in a regulated pharmaceutical environment and ensuring compliance with GxP requirements, internal procedures, and applicable regulatory standards.

Key Responsibilities:

• Execute and manage CSV activities in accordance with regulatory requirements and internal SOPs.
• Support software validation for new implementations, system updates, and software releases.
• Manage system updates, release changes, and packaging-related changes while maintaining compliance.
• Coordinate and document Change Controls using TrackWise.
• Use KNEAT to prepare, manage, and maintain validation documentation.
• Support onsite configuration, setup, and qualification of analytical laboratory equipment.
• Develop and review system lifecycle documents, including risk assessments, requirements, validation protocols, and reports.
• Lead or support qualification activities for LC, Mass Spectrometry, GC, UPLC, ICP, and pH meters.
• Maintain accurate, complete, and audit-ready validation records.

Key Skills & Qualifications:

• Hands-on experience in Computer System Validation within the pharmaceutical industry.
• Knowledge of GxP compliance and software lifecycle management.
• Experience qualifying analytical laboratory instruments, including LC, Mass Spectrometry, GC, UPLC, ICP, and pH meters.
• Experience managing software updates, release changes, and Change Controls.
• Familiarity with TrackWise and KNEAT validation documentation systems.
• Experience with equipment configuration, setup, and qualification.
• Strong documentation, troubleshooting, and cross-functional collaboration skills.