CSV Engineer

Novozen Healthcare LLC; Indiana (PA); On-site; USD 80,000 - 100,000; Full time

Job summary

A healthcare solutions provider based in Indiana is seeking a CSV Engineer to be responsible for the qualification and validation of laboratory analytical instruments. The role requires at least 5 years of experience in Computer System Validation (CSV) within a GMP-regulated environment. The CSV Engineer will execute validation processes, maintain documentation, and support system administration. This contract position is ideal for candidates with strong interpersonal and communication skills and offers a duration of 12 months.

Qualifications

• Minimum of 5 years of experience in Computer System Validation (CSV) in a laboratory environment.
• Experience in a GMP-regulated laboratory.
• Strong organizational skills and attention to detail.

Responsibilities

• Execute Computer System Validation (CSV) activities and laboratory instrument qualification.
• Review and maintain validation documentation.
• Support system administration tasks.

Skills

Computer System Validation (CSV)

Knowledge of 21 CFR Part 11

Interpersonal skills

Attention to detail

Strong communication skills

Education

Bachelor’s degree in Biology, Chemistry, Engineering, or Computer Science

Tools

GMARS

TrackWise

Kneat

Job description

CSV Engineer

Job Title: CSV Engineer

Location: Carmel, IN

Duration: 12 Months (potential extension)

Position Summary

The CSV Engineer is responsible for the qualification and validation of laboratory analytical instruments and associated computer systems within a regulated biotechnology or pharmaceutical environment. This role supports the full instrument lifecycle, including software installation, configuration, validation documentation, compliance activities, and ongoing system support in accordance with regulatory and quality requirements.

Key Responsibilities

• Execute Computer System Validation (CSV) activities and laboratory instrument qualification
• Author, review, and maintain validation documentation, including protocols and reports
• Support system administration tasks such as user access management, system upgrades, and configuration control
• Perform compliance activities, including periodic reviews and audit trail reviews
• Configure and, when required, install software associated with laboratory instruments
• Provide technical support throughout the instrument lifecycle, including defining IT infrastructure requirements such as data backup and recovery strategies
• Develop and maintain standard operating procedures (SOPs) for equipment operation and system use
• Collaborate with cross-functional teams and external vendors to address validation and compliance requirements
• Participate in data integrity initiatives related to computer systems and secure desktop installation and configuration

Required Qualifications

• Minimum of 5 years of experience in Computer System Validation (CSV) for laboratory analytical instruments
• Strong knowledge of 21 CFR Part 11 and experience working in a GMP-regulated laboratory environment
• Familiarity with compliance and quality systems tools such as GMARS, TrackWise, and Kneat
• Excellent written and verbal communication skills
• Strong interpersonal skills with the ability to work effectively across teams
• Highly organized with strong attention to detail and accuracy

Education

• Bachelor’s degree in Biology, Chemistry, Engineering, Computer Science, or a related scientific or technical discipline

Seniority Level

Mid-Senior level

Employment Type

Contract

Job Function

Science and Engineering

Industries

Medical Equipment Manufacturing, Pharmaceutical Manufacturing, Biotechnology Research

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