CSV Engineer

Intellectt INC; Indiana; On-site; USD 62,000 - 68,000; Full time

Job summary

Intellectt INC in Indianapolis, IN currently seeks a Computer System Validation (CSV) Engineer to support validation activities for pharmaceutical computer systems and analytical lab equipment. The role focuses on software lifecycle management, equipment qualification, change controls, and regulatory compliance in a GxP-regulated environment.

You will execute CSV tasks, validate software for new implementations and updates, manage change controls with TrackWise, document validation activities

Qualifications

• Hands-on CSV in pharma/GxP environments.
• Experience with analytical lab equipment qualification (LC, MS, GC, UPLC, ICP, pH meters).
• Knowledge of software lifecycle management, validation protocols, and release changes.
• Experience with change control processes and TrackWise.
• Familiarity with Kneat for validation documentation.
• Understanding of GxP compliance and audit-ready documentation practices.
• Ability to work onsite in Indianapolis, IN.

Responsibilities

• Execute CSV activities in line with GxP requirements and SOPs.
• Support software validation for new implementations, updates, releases, and packaging changes.
• Manage and support change controls using TrackWise with cross-functional teams.
• Use Kneat to document validation activities and maintain audit-ready records.
• Support onsite configuration, setup, and qualification of analytical lab equipment.
• Prepare and maintain validation documentation, including risk assessments, requirements, protocols, and reports.
• Lead or support qualification activities for LC, MS, GC, UPLC, ICP systems, and pH meters.
• Ensure validation docs and lifecycle records remain accurate and compliant.

Skills

CSV experience

GxP compliance

TrackWise change control

Kneat validation docs

Analytical lab equipment qualification

Regulatory documentation

Onsite Indianapolis

Tools

TrackWise

Kneat

LC

Mass spectrometry

GC

UPLC

ICP

Job description

Title : CSV Engineer

Location: Indianapolis, IN

Employment Type: Contract W2

Duration: 12 Months

Industry: Pharmaceutical / Life Sciences

About the Role

We are seeking a Computer System Validation (CSV) professional to support validation activities for pharmaceutical computer systems and analytical laboratory equipment. The role focuses on software lifecycle management, equipment qualification, change controls, and regulatory compliance in a GxP-regulated environment.

Responsibilities

• Execute CSV activities in accordance with GxP requirements, applicable regulations, and internal SOPs.
• Support software validation for new implementations, system updates, releases, and packaging-related changes.
• Manage and support change controls using TrackWise in collaboration with cross-functional teams.
• Use Kneat to document validation activities and maintain audit-ready records.
• Support onsite configuration, setup, and qualification of analytical laboratory equipment.
• Prepare and maintain validation documentation, including risk assessments, requirements, protocols, and reports.
• Lead or support qualification activities for analytical laboratory equipment, including LC, mass spectrometry, GC, UPLC, ICP systems, and pH meters.
• Ensure validation documentation and system lifecycle records remain accurate and compliant.

Required Qualifications

• Hands-on experience in Computer System Validation within a pharmaceutical or GxP-regulated environment.
• Experience with analytical laboratory equipment qualification, such as LC, mass spectrometry, GC, UPLC, ICP, or pH meters.
• Knowledge of software lifecycle management, validation protocols, and release changes.
• Experience with change control processes and TrackWise.
• Familiarity with Kneat for validation documentation.
• Understanding of GxP compliance and audit-ready documentation practices.
• Ability to work onsite in Indianapolis, IN.

Salary

The hourly rate for this position is $45-49hr on W2, depending on experience and qualifications.

Benefits

Eligible employees may have access to benefits in accordance with the applicable benefit plans and eligibility requirements.

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check

Background checks may be conducted in accordance with applicable law.

Work Authorization

Applicants must be authorized to work in the United States.