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Biotech Csv Jobs (NOW HIRING)

Moriah Engineering

PR · On-site

$90K - $118K/yr

CSV Leadto oversee the validation of major capital automation projects. The ideal candidate will ... A background in the biotechnology industry is preferred. Key Responsibilities: * Lead validation ...

Moriah Engineering

CSV Lead

Carolina, PR · On-site

$90K - $118K/yr

CSV Leadto oversee the validation of major capital automation projects. The ideal candidate will ... A background in the biotechnology industry is preferred. Key Responsibilities: * Lead validation ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR

Minimum of 5 years of hands-on experience in Computer System Validation within the pharmaceutical or biotechnology industry. * Strong knowledge of CSV lifecycle methodology, 21 CFR Part 11, Annex 11 ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR

Minimum of 5 years of hands-on experience in Computer System Validation within the pharmaceutical or biotechnology industry. * Strong knowledge of CSV lifecycle methodology, 21 CFR Part 11, Annex 11 ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

Minimum of 5 years of hands-on experience in Computer System Validation within the pharmaceutical or biotechnology industry. * Strong knowledge of CSV lifecycle methodology, 21 CFR Part 11, Annex 11 ...

Nanda Technologies

CSV Engineer

Costa Mesa, CA · On-site

$55 - $60/hr

CSV Engineer Costa Mesa, CA or Seattle, WA(On-site) Visa: USC, GC & H4 EAD Key Responsibilities ... biotechnology, or life sciences industries. * Direct experience with GxP equipment, IT systems, or ...

Eliquent Life Sciences, Inc

CSV Engineer

Mount Horeb, WI · On-site

$120K - $135K/yr

The CSV Engineer will author validation deliverables--including protocols, reports, and SOPs ... biotechnology, or life sciences industries. * Working knowledge of: * FDA and cGMP regulations and ...

JC Automation Corp

PR · On-site

$70K - $92K/yr

Minimum 4 years of progressive, hands-on experience in Computer System Validation (CSV) or Automation Quality within the pharmaceutical or biotechnology manufacturing industry. * Proven track record ...

Validation & Engineering Group, Inc

PR

$57K - $58K/yr

... Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory ... Associate CSV - Periodic Review Scientist Position Summary The Associate CSV Periodic Review ...

Validation & Engineering Group, Inc

PR

$59K - $60K/yr

... Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory ... Associate CSV - Periodic Review Scientist Position Summary The Associate CSV Periodic Review ...

Forge Biologics

CSV Engineer I

Columbus, OH

We partner with scientists, physicians, biotech and pharma innovators, and patient communities ... The CSV Engineer I is responsible for ensuring that GxP computerized systems at Forge Biologics are ...

Forge Biologics

CSV Engineer I

Columbus, OH

We partner with scientists, physicians, biotech and pharma innovators, and patient communities ... The CSV Engineer I is responsible for ensuring that GxP computerized systems at Forge Biologics are ...

Compunnel

CSV Technical Specialist

Coral Springs, FL · On-site

$106K/yr

JOB SUMMARY The GxP IT Systems Support / CSV Technical Contractor is responsible for providing ... biotech, or similarly regulated environments. • Hands-on experience with system administration ...

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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

CSV Lead

Moriah Engineering

PR • On-site

$90K - $118K/yr

Contractor

Posted 12 days ago

Job description

Salary:
CSV Leadto oversee the validation of major capital automation projects. The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with DeltaV, Aveeva PI. A background in the biotechnology industry is preferred.
Key Responsibilities:
  • Lead validation activities for major capital automation projects, ensuring compliance with industry regulations and best practices.
  • Assure the development of the validation protocols, includingInstallation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Ensure adherence toGxP guidelinessuch asGood Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
  • Maintain compliance with regulatory standards, includingFDA 21 CFR Part 11 and ISO 9001.
  • OverseeComputer System Validation (CSV)processes, including risk-based validation, system integration, interface testing, and data integrity assessments.
  • Collaborate with cross-functional teams to validate automation systems, includingSCADA and Aveeva Pi.
  • Prepare and maintain validation documentation, including protocols, reports, traceability matrices, and deviation records.