Pharma CSV Contractor: Hands-On Validation & Compliance

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

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.