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Computer System Validation Csv Pharmaceutical Jobs in Oregon

Natera

Comp. Sys Validation Spec

OR · On-site +1

... computer system validation projects * Draft IQ/OQ/PQ software plans, protocols, and reports * Ensure validation state of software systems are maintained * Act as subject matter expert for CSV ...

Tailored Management

Validation Engineer 2

Bend, OR · On-site

$70.92 - $99.29/hr

System Retirement Documentation * Support qualification and validation activities for new and ... Experience * 35+ years of CQV and/or CSV experience within pharmaceutical, biotechnology, medical ...

Genentech

Senior Quality Assurance Engineer

Hillsboro, OR · On-site

$93 - $172.80/hr

... Computer System Validation (CSV). * Approve Critical Validation: Review and approve essential ... pharmaceutical/biopharmaceutical industry experience, or a Master's degree with a minimum of 6 ...

Genentech

Senior Quality Assurance Engineer

Hillsboro, OR · On-site

$93K - $172K/yr

... Computer System Validation (CSV). * Approve Critical Validation: Review and approve essential ... pharmaceutical/biopharmaceutical industry experience, or a Master's degree with a minimum of 6 ...

Shimento, Inc.

CQV Validation Specialist

Bend, OR · On-site

System Retirement Documentation * Support qualification and validation activities for new and ... Minimum 3-5 years of CQV and/or CSV experience within pharmaceutical, biotechnology, or other ...

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 ...

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Computer System Validation Csv Pharmaceutical information

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 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 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 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:

What cities in Oregon are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities in Oregon with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you

Senior CSV Engineer / MES Validation Lead

Adryan B.V

Bend, OR • On-site

$120 - $170/hr

Other

Posted 7 days ago

Job description

We are looking for a senior CSV professional with strong, hands-on Manufacturing Execution System (MES) validation experience who can independently lead an MES validation workstream in a GMP manufacturing environment.

The Opportunity

Adryan is looking for an experienced Senior Computer System Validation (CSV) Engineer / MES Validation Lead to support a pharmaceutical manufacturing site in Oregon. The successful candidate will take ownership of CSV activities with a strong focus on MES and related manufacturing systems, working closely with Manufacturing, Automation, Engineering, IT/OT and Quality.

Ideally someone who understands how an MES operates in a pharmaceutical manufacturing environment, can translate manufacturing processes into validated system requirements, and can drive the MES validation lifecycle from requirements through testing, release and change control.

Key Responsibilities
  • Lead and execute CSV activities for MES and associated manufacturing systems.
  • Own or lead the MES validation workstream, including planning, risk assessment, documentation, testing and release.
  • Develop and review Validation Plans, URS, functional/design specifications, risk assessments, traceability matrices, IQ/OQ/PQ protocols, test scripts and Validation Summary Reports.
  • Support implementation, configuration, upgrade, expansion and lifecycle management of MES solutions.
  • Translate manufacturing processes, electronic batch records and GMP requirements into MES system and validation requirements.
  • Apply risk-based validation in accordance with GAMP 5 and modern CSA principles where appropriae.
  • Ensure compliance with 21 CFR Part 11, EU GMP Annex 11 and Data Integrity / ALCOA+ expectations.
  • Assess changes to MES and connected systems through formal change control and validation impact assessment.
  • Support deviations, investigations, CAPAs, troubleshooting and inspection readiness related to computerized systems.
  • Validate interfaces between MES and systems such as ERP, LIMS, DCS, SCADA, PLC.
  • Coordinate effectively across Manufacturing, Automation, IT/OT, Engineering and Quality and drive validation activities to agreed milestones.
Required Experience
  • 7+ years of CSV experience in pharmaceutical, biotechnology or another regulated life-sciences environment.
  • Strong, demonstrable hands-on MES validation experience is essential.
  • Experience leading or independently owning an MES/CSV workstream.
  • Strong knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11, Data Integrity and risk-based validation.
  • Experience across the full computerized system lifecycle: requirements, design review, testing, qualification, release, change control and periodic review.
  • Experience working directly within a GMP manufacturing environment.
  • Ability to communicate effectively with Manufacturing, Automation, IT/OT, Engineering and QA stakeholders.
  • Strong documentation, troubleshooting and stakeholder-management skills.
  • Ability to work independently and deliver in a fast-paced project environment.
Highly Preferred
  • Experience with Werum / Körber PAS-X, Rockwell PharmaSuite, Siemens Opcenter or another enterprise MES platform.
  • MES integration with ERP, LIMS, DCS, SCADA, PLC or historian systems.
  • Electronic Batch Records (EBR/eBR), recipe management and master batch record configuration.
  • MES equipment integration, automation interfaces, data migration and system interfaces.
  • CSA / risk-based assurance approaches and validation of manufacturing automation systems.
  • Experience in Oral Solid Dosage, drug product, small-molecule manufacturing, spray drying or related pharmaceutical operations.
  • Experience in greenfield, expansion or major system implementation projects.
About Adryan

Adryan is an international engineering and quality consultancy dedicated to the pharmaceutical and biotechnology industry. We support leading life-sciences organizations across Europe and the United States with specialized expertise in Commissioning & Qualification, Computer System Validation, Quality & Compliance, Engineering and Project Management.

For this assignment we are looking for a senior professional who can make an immediate impact, strengthen our delivery in Oregon and become an important part of our growing US project organization.

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