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Computer System Validation Csv Pharmaceutical Jobs

Mirus Consulting Group

CSV Specialist

Gurabo, PR

... computer system validation and information technology consulting services to pharmaceutical ... The CSV Specialist will be responsible for managing and executing all activities related to ...

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Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... computer system validation and information technology consulting services to pharmaceutical ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... computer system validation and information technology consulting services to pharmaceutical ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Sunrise Systems Inc

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Computer Systems Validation Engineer (MES)_26-02885

Bothell, WA · On-site

$73 - $75/hr

Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support ... InfoBatch). * Understanding of computer system validation (CSV). Education and Experience:

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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 Jul 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 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.

What are some 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, and why are they important?

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 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.
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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 June 2026, with employment types broken down into 8% Internship, 34% As Needed, 8% Full Time, 25% Temporary, and 25% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.
Computer System Validation (CSV) Lead

Computer System Validation (CSV) Lead

Intellectt INC

Lancaster, PA • On-site

Contractor

Posted 12 days ago

Be an early applicant

Job description

Hello,

I hope you're doing well.

My name is Mahalakshmi, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Computer System Validation (CSV) Lead based in Lancaster, PA with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at mahalakshmi.n@intellectt.com  OR +1 (732) 737 8381

Job Title: Computer System Validation (CSV) Lead
Location: Lancaster, PA

Position Summary

We are seeking an experienced Computer System Validation (CSV) Lead to support validation activities for a newly constructed Sterile Drug Product Clinical Manufacturing Facility. This role will lead CSV strategy, execution, and compliance activities for GMP computerized systems and automation platforms in a fast-paced project environment.

Key Responsibilities

  • Lead CSV strategy and execution for GMP computerized systems and automation platforms.
  • Author and execute CSV lifecycle documents including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
  • Support commissioning, qualification, and validation activities for manufacturing and automation systems.
  • Collaborate with Automation, Engineering, Quality, Manufacturing, and IT teams.
  • Lead deviation investigations, troubleshooting, and validation issue resolution.
  • Ensure compliance with GAMP5, 21 CFR Part 11, Data Integrity, and company validation standards.
  • Support testing and validation of control systems, SCADA/HMI platforms, instrumentation, OT infrastructure, and manufacturing equipment.

Required Qualifications

  • Bachelor’s degree in Engineering, Computer Science, Automation, Life Sciences, or related field.
  • 10–15 years of CSV, Automation, or Validation Engineering experience in pharmaceutical or biotech industries.
  • Strong experience in GMP manufacturing environments, preferably sterile or aseptic processing facilities.
  • Hands-on experience with CSV documentation, protocol execution, and validation lifecycle management.
  • Strong knowledge of GAMP5, 21 CFR Part 11, CSA/CSV methodologies, and Data Integrity principles.
  • Excellent technical writing, troubleshooting, and communication skills.

Preferred Technical Experience

  • AVEVA System Platform, Allen Bradley PLC, Siemens PLC, PI Historian, SCADA/HMI systems.
  • OT networks, instrumentation, industrial communications, and field I/O testing.
  • Experience with robotic isolators, filling lines, lyophilizers, autoclaves, and wash systems.
  • Kneat validation platform experience preferred.

Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc 
mahalakshmi.n@intellectt.com
Direct: +1 (732) 737 8381