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Computer System Validation Csv Pharmaceutical Jobs

ClinDCast, LLC

CSV Consultant

Raritan, NJ · On-site

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV ... Experience in the pharmaceutical, biotechnology, or medical device industry. * Excellent ...

ClinDCast LLC

CSV Consultant

Raritan, NJ · On-site

$45 - $50/hr

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV ... Experience in the pharmaceutical, biotechnology, or medical device industry. * Excellent ...

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Computer System Validation Csv Pharmaceutical information

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How much do computer system validation csv pharmaceutical jobs pay per hour?

As of Sep 1, 2026, the average hourly pay for computer system validation csv pharmaceutical in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 per hour, depending on experience, location, and employer.

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

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Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 13% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Computer System Validation (CSV) Engineer

Spadtek Solutions LLC

Piscataway, NJ • On-site

Other

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Title : Computer System Validation (CSV) Engineer
Locations: Piscataway, NJ  | Chicago, IL 
Work Arrangement: Onsite
Employment Type: Full-Time
Experience: 5+ Years of CSV Experience in a GxP-Regulated Environment

Job Summary

We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, manufacturing and engineering equipment, and enterprise applications.

The CSV Engineer will work closely with Quality, IT, Laboratory, and Manufacturing teams to ensure computerized systems remain validated and compliant with GxP, 21 CFR Part 11, EU Annex 11, and applicable EMA requirements.

This is an onsite position reporting to the Sr. Director of IT. The successful candidate will have strong hands-on experience developing and executing CSV deliverables within a regulated life sciences environment.

Key Responsibilities
  • Plan, author, review, and execute CSV deliverables, including:
    • Validation Plans
    • User Requirements Specifications (URS)
    • Functional Specifications (FS)
    • Design Specifications (DS)
    • IQ/OQ/PQ protocols
    • Traceability Matrices
    • Validation Summary Reports (VSR)
  • Perform CSV activities for:
    • Laboratory instruments such as HPLC, spectrophotometers, and balances
    • Engineering and manufacturing equipment
    • LIMS platforms
    • SAP systems
    • CMMS/calibration systems such as BMRAM
  • Partner with System Owners, QA, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state.
  • Support change control, periodic reviews, and validation lifecycle activities.
  • Conduct computerized system risk assessments and data integrity assessments in alignment with ALCOA+ principles.
  • Support audits, regulatory inspections, CAPA investigations, deviations, and compliance activities related to computerized systems.
  • Collaborate with senior validation leads and subject matter experts to establish and maintain consistent CSV practices across sites.
  • Ensure validation documentation meets applicable regulatory and quality standards.
Required Qualifications
  • Bachelor's degree in Life Sciences, Engineering, Information Technology, or a related field, or equivalent laboratory experience within a life sciences environment.
  • Minimum 5 years of Computer System Validation (CSV) experience in a GxP-regulated environment.
  • Strong working knowledge of:
    • 21 CFR Part 11
    • EU Annex 11
    • EMA guidance
    • GxP compliance requirements
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols.
Preferred Qualifications
  • Familiarity with GAMP 5 principles.
  • Experience with risk-based validation methodologies.
  • Exposure to Caliber LIMS.
  • Experience with SAP QM, MM, or PP in a GxP environment.
  • Experience with BMRAM or comparable CMMS/calibration systems.
  • Experience working as a liaison between IT, Quality, Laboratory, and Manufacturing teams.
  • Strong understanding of computerized system lifecycle management and data integrity principles.

Apply