Automation Validation
Company: Yoh, A Day & Zimmermann Company
Location: Saratoga
Posted on: February 24, 2021
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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, Greenville , Automation Validation, Other , Saratoga, North Carolina
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