Computer System Validation Engineer
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Overview
Remote
On-site
Compensation
$85-$90/hour
Job Description
Job Title: Computer System Validation Engineer Location: Bothell, WA Pay Rate: $85-$90 Key Responsibilities Author, review and/or approve applicable CSV documentation Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations Other related duties as assigned Team Structure how does this role fit with the team This role is an individual contributor and will cross-functionally to lead and execute validation activities for GxP electronic systems and application. Role in Team This individual will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) and other computerized systems are documented in accordance with the relevant Client procedures and regulations. Must-have Qualifications " GMP manufacturing experience " Flexibility to work as per Shift Schedule " Adheres to Good Manufacturing Practices and standard operating procedures. " Completes work instructions and maintains clean room environment to comply with regulatory requirements. " Primary focus on MES validation knowledge Nice-to-have Qualifications Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch). Technical Skills Computer system validation (document and protocol generation, execution) Non-Technical Skills Good communication, self project management Additional Standout Experience Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.) Experience Field Details Required Experience At least 3 years in CSV Preferred Experience 4 years in CSV Overqualified Indicators / Similar Titles Management of CSV engineers, performing only review and approval of validation documents Target Companies Open to review profiles from companies with CSV exp. Education & Certifications Field Details Education Required Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education Education Preferred N/A Certifications Required N/A Certifications Preferred N/A
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FAQs About Computer System Validation Engineer Jobs at Artech LLC
What is the work location for this position at Artech LLC?
This job at Artech LLC is located in Bothell, WA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Artech LLC?
Candidates can expect a pay range of $85–$90 per hour for this role.
What employment applies to this position at Artech LLC?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Artech LLC?
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