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Orion Innovation
Olympia, WA
Source: Orion Innovation careers · View original posting
From Orion Innovation's posting. “We” and “our” refer to the employer.
Orion Innovation is a premier, award-winning, global business and technology services firm. Orion delivers game-changing business transformation and product development rooted in digital strategy, experience design, and engineering, with a unique combination of agility, scale, and maturity. We work with a wide range of clients across many industries including financial services, professional services, telecommunications and media, consumer products, automotive, industrial automation, professional sports and entertainment, life
sciences, ecommerce, and education.
The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor 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) are documented in accordance with the relevant BMS procedures and regulations.
Skills
MES experience Required unicorn
Syncade.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
· Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement) 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
· Strong knowledge on Manufacturing Execution System (MES) validation.
· Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
· 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.)
(“Notice”) explains:
What information we collect during our application and recruitment process and why we collect it; How we handle that information; and
How to access and update that information.
Your use of Orion services is governed by any applicable terms in this notice and our general
Privacy Policy.
Orion is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, citizenship status, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
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