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Automation Validation

Company: Yoh, A Day & Zimmermann Company
Location: Spring Hope
Posted on: February 24, 2021

Job Description:

Yoh is a seeking a Automation Validation Engineer to support a Wilson area based company.

Title: Automation Validation Engineer

Location: Wilson, NC

Industry: Biotechnology/Pharmaceutical

Primary responsibilities for role:


Develop and execute Computerized System Validation (CSV) deliverables for control systems for production equipment including but not limited to Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Trace Matrices, Test Execution, Summary reports. CSV will be specific to automated process equipment and interfaces.


Requirements:


Education: Bachelor's degree in Engineering or related science studies.
Prefer five (5) + years related work experience including strong knowledge and hands-on experience of computer system validation (CSV) activities in the regulated industries.
Strong technical writing skills


Essential Skills:


Understanding and experience with CSV regulations and guidelines such as FDA; cGMP for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance with CGMP Guidance for Industry; and ISPE GAMP5.
Strong knowledge of the development and execution of CSV deliverables throughout the System Development Life Cycle (SDLC)
Knowledge, familiarity and exposure to industrial control systems (PCS, Siemens PLC, or related), including related configuration/programming.
Strong technical writing skills


Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic.Category: Engineering, Keywords: Automation Engineer

Keywords: Yoh, A Day & Zimmermann Company, Raleigh , Automation Validation, Other , Spring Hope, North Carolina

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