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Computer System Validation Csv Pharmaceutical Jobs in Oregon

Intellectt INC

Senior Validation Engineer

Portland, OR · On-site

Seeking a Senior Validation Engineer with strong GMP experience to support QC equipment validation and Computer System Validation (CSV) activities. Key Responsibilities: * Author & execute URS, IQ/OQ ...

Arcus Biosciences

... requirements, Computer Systems Validation (CSV) and lifecycle procedures, and data integrity ... pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments. • ...

Syner-G

Sr. Validation Engineer

Hillsboro, OR

Technical Experience * 7-11 years of experience in the biotech, pharmaceutical, or medical device ... Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ...

Syner-G

Sr. Validation Engineer

Hillsboro, OR · On-site

Technical Experience * 7-11 years of experience in the biotech, pharmaceutical, or medical device ... Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ...

Syner-G

Sr. Validation Engineer

Hillsboro, OR · On-site

Technical Experience * 7-11 years of experience in the biotech, pharmaceutical, or medical device ... Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ...

Genentech

ITOT Infrastructure Engineer

Hillsboro, OR · On-site

$95K - $176K/yr

Execute computer system validation and control system lifecycle management. * Support the ... Pharmaceutical) industry. * 24X7 environment, participate in an on-call environment to meet ...

Seran BioScience

Senior Validation Engineer

Bend, OR

... systems to support commercial distribution of non-sterile pharmaceutical products. Experience will ... Prolonged periods of sitting or standing at a desk and working on a computer * Prolonged periods of ...

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Computer System Validation Csv Pharmaceutical information

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 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 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 popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Oregon? For Computer System Validation Csv Pharmaceutical jobs in Oregon, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Oregon look for? The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Oregon are:
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Computer System Validation Csv Pharmaceutical jobs near you

Senior Validation Engineer

Intellectt INC

Portland, OR • On-site

Contractor

This job post has expired today. Applications are no longer accepted.

Job description

Hello, 
I Hope you are doing great. 

This is Mahaboob from Intellectt INC; we’ve got an important Senior Validation Engineer - Oregon with one of our prestigious clients. Interested candidates can please send your updated resume at mahaboob.m@intellectt.com

Title: Senior Validation Engineer
Location: Oregon

Summary: Seeking a Senior Validation Engineer with strong GMP experience to support QC equipment validation and Computer System Validation (CSV) activities.
Key Responsibilities:

  • Author & execute URS, IQ/OQ/PQ, risk & data integrity assessments
  • Support CSV (ValGenesis preferred)
  • Manage full lifecycle of QC equipment (qualification to requalification)
  • Support analytical method transfers & vendor coordination
  • Ensure compliance with GMP & ALCOA+

Requirements:

  • 5+ years validation experience in GMP environment
  • Hands-on with HPLC, GC, bioassay systems
  • Strong CQV, QC Equipment & CSV experience

Thanks & Regards,
Mahaboob M
Technical Recruiter
Intellectt Inc 
mahaboob.m@intellectt.com
Direct: 732-276-1830
Desk number: 732 412 6999- Ext: 355