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Csv Engineer Jobs (NOW HIRING)

Bristol-Myers Squibb Company

Lead Engineer, CSV

Summit, NJ · On-site

$108K - $143K/yr

The Lead CSV Engineer, Equipment Commissioning & Qualification (ECQ) supports the successful configuration, implementation and support of manufacturing and laboratory equipment and computerized ...

PCI Pharma Services

CSV Engineer III

Bedford, NH · On-site

$71K - $91K/yr

We're looking for a CSV Validation Engineer III to join our Quality and Compliance team. In this role, you'll take the lead in developing and executing validation strategies for GxP computer systems ...

Bristol Myers Squibb

Lead Engineer, CSV

Summit, NJ · On-site

$108K - $143K/yr

The Lead CSV Engineer, Equipment Commissioning & Qualification (ECQ) supports the successful configuration, implementation and support of manufacturing and laboratory equipment and computerized ...

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How much do csv engineer jobs pay per year?

As of Jun 5, 2026, the average yearly pay for csv engineer in the United States is $99,411.00, according to ZipRecruiter salary data. Most workers in this role earn between $77,000.00 and $116,500.00 per year, depending on experience, location, and employer.

What is a CSV Engineer job?

A CSV (Computer System Validation) Engineer is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, comply with regulatory requirements. They develop validation protocols, perform testing, document results, and ensure adherence to industry standards like FDA 21 CFR Part 11 and GAMP 5. Their goal is to confirm that software and hardware systems function correctly, maintain data integrity, and meet compliance requirements.

What are the key skills and qualifications needed to thrive in the Csv Engineer position, and why are they important?

To thrive as a CSV Engineer (Computer System Validation Engineer), you need a solid understanding of validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a relevant degree in life sciences, engineering, or information technology. Familiarity with validation lifecycle documentation, risk assessment tools, and industry-standard systems like SAP, LIMS, and TrackWise is highly valued, as are certifications such as GAMP or Six Sigma. Strong attention to detail, analytical thinking, and excellent communication skills help CSV Engineers collaborate efficiently with cross-functional teams and ensure thorough documentation. These skills are crucial to guarantee that computerized systems in regulated industries meet compliance requirements, supporting product quality and patient safety.

What are the common challenges faced by a CSV Engineer in the pharmaceutical or medical device industry?

CSV Engineers in the pharmaceutical or medical device industry often face the challenge of keeping up with evolving regulatory requirements and ensuring all computerized systems remain compliant throughout their lifecycle. Managing comprehensive documentation, coordinating with multiple departments, and troubleshooting complex system changes can add to the workload. Successful CSV Engineers are proactive about staying informed of regulatory updates, are highly organized, and collaborate closely with Quality Assurance, IT, and operations teams. This dynamic environment offers the opportunity to learn continuously, develop expertise in validation best practices, and advance into leadership or specialized quality roles.
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Csv Engineer jobs near you
Infographic showing various Csv Engineer job openings in the United States as of May 2026, with employment types broken down into 4% Internship, 8% Full Time, 25% Part Time, 3% Temporary, 56% Contract, and 4% Nights. Highlights an 79% Physical, 4% Hybrid, and 17% Remote job distribution, with an average salary of $99,411 per year, or $47.8 per hour.
Urgent On-Site Opening for Senior CSV Engineer - Needham, MA - Need Local to MA Only.

Urgent On-Site Opening for Senior CSV Engineer - Needham, MA - Need Local to MA Only.

SmartIPlace

Needham, MA • On-site

$113K - $156K/yr

Contractor

Posted 28 days ago

Job description

Note :

  • Need Local to MA, with same State I’d Only.

Position Overview :

  • Need someone with Lab experience.
  • We are looking for 4 Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Candel’s QC Laboratory reactivation project.
  • This role will focus on EMS, BMS, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, SciNotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements.
  • The CSV Engineer will develop and execute validation deliverables, manage ERES assessments, and provide GMP-ready reports within the accelerated project schedule.

Tasks, Responsibilities, and Deliverables:

  • Draft and execute URS for computerized lab systems and informatics platforms.
  • Perform and document risk assessments and ERES (Electronic Records and Electronic Signatures) assessments.
  • Develop and execute validation deliverables: FS/DS, IQ, OQ, PQ protocols, and traceability matrices.
  • Validate EMS/BMS systems for environmental monitoring and building controls.
  • Validate laboratory software platforms, including HPLC/qPCR data systems, SciNotes, and Blue Mountain.
  • Verify compliance with data integrity principles (ALCOA+), Part 11, and Annex 11 requirements.
  • Document results, deviations, and resolution activities.
  • Deliver complete GMP-ready CSV reports for QA review and approval.
  • Collaborate with CQV Engineers, Technical Writers, and QA to ensure consistency across FEU, LEQ, and CSV validation workstreams.

Required Skills, Scope, and Experience:

  • Bachelor’s degree in Computer Science, Engineering, or related technical field.
  • 8–10 years’ experience in computer system validation within GMP-regulated pharmaceutical/biotech environments.
  • Strong knowledge of 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5.
  • Proven experience validating EMS, BMS, and laboratory informatics/data systems.
  • Proficiency in authoring and executing FS/DS, IQ, OQ, PQ, and trace matrices.
  • Experience performing ERES assessments and applying risk-based validation approaches.
  • Familiarity with eQMS or informatics platforms (e.g., SciNotes, Blue Mountain, Empower, LabWare).
  • Strong technical writing and documentation skills.
  • Ability to manage parallel CSV activities in a compressed timeframe with accuracy and compliance.
     
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About Smart-iPlace

Sourced by ZipRecruiter

SMART-iPLACE provides innovative staffing and consulting solutions that help our clients achieve their business objectives. We can understand and support all areas of your IT systems from back-end infrastructure to front-end personal productivity. Our goal is create innovative IT solutions that enable your business to be more agile and competitive.

Industry

It services

Company size

51 - 200 Employees

Headquarters location

Irving, TX, US

Year founded

2021

Social media

Facebook

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