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Biotech Csv Jobs (NOW HIRING)

Zifo

CSV Validation Analyst

Emeryville, CA · On-site

Knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV process * Familiarity with broad ... We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering ...

Zifo

CSV Validation Analyst

Emeryville, CA · On-site

Knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV process * Familiarity with broad ... We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering ...

PSC Biotech

LabWare Specialist

Ventura, CA · On-site

PSC Biotech provides the life sciences with essential services to ensure that health care products ... Validation & CSV Support * Support Computer System Validation (CSV) activities for LabWare ...

PSC Biotech

LabWare Specialist

Thousand Oaks, CA · On-site

$85K - $115K/yr

PSC Biotech provides the life sciences with essential services to ensure that health care products ... Validation & CSV Support * Support Computer System Validation (CSV) activities for LabWare ...

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Biotech Csv information

What are some common challenges faced by Biotech CSV professionals when ensuring compliance with regulatory standards?

Biotech CSV (Computer System Validation) professionals often encounter challenges such as keeping pace with evolving regulatory requirements and ensuring that validation documentation is both thorough and audit-ready. Navigating the complexity of integrating new software or technologies into existing validated systems can also be demanding. Effective communication with cross-functional teams—such as quality assurance, IT, and laboratory staff—is crucial to address gaps and maintain compliance. Staying organized and proactive in risk management helps CSV professionals overcome these hurdles and support successful regulatory inspections.

What are Biotech CSV professionals?

Biotech CSV (Computer System Validation) professionals are experts who ensure that computerized systems used in biotechnology and pharmaceutical industries meet regulatory requirements and function as intended. They are responsible for planning, executing, and documenting validation activities to ensure data integrity, product quality, and compliance with standards such as FDA 21 CFR Part 11. Their role is crucial in maintaining reliable and compliant technology solutions throughout the product lifecycle, helping companies avoid costly errors and regulatory penalties.

What are the key skills and qualifications needed to thrive as a Biotech CSV (Computer System Validation) Specialist, and why are they important?

To thrive as a Biotech CSV Specialist, you need a solid understanding of computer system validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, quality management systems (QMS), and relevant software like TrackWise or MasterControl is crucial. Strong analytical thinking, attention to detail, and effective communication are standout soft skills in this role. These skills and qualities ensure validated systems meet regulatory standards, minimize compliance risks, and support reliable biotech research and manufacturing processes.
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Biotech Csv jobs near you
Infographic showing various Biotech Csv job openings in the United States as of June 2026, with employment types broken down into 93% Full Time, 1% Temporary, and 6% Contract. Highlights an 83% Physical, 2% Hybrid, and 15% Remote job distribution.
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 22 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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