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Validation Engineer CSV (Mainz )

Rodgau, Germany | Remote

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Responsibilities

Location Rodgau, HesseDE Job ID JR-030974

Location: Mainz Umgebung

Job Purpose:

  • Support Compliance Projects and Programs

Core Job Duties:

  • Design, Author, and Execute Computerized System Validation (CSV) – according to GAMP 5 guidance – especially on Analytical Laboratory Test Equipment and other Lab Information Systems

  • Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents

  • Translate technical information and requirements into qualification/validation test design

  • Contribute to the overall growth of PerkinElmer’s compliance business

Qualifications, Skills & Experience:

  • Bachelor’s Degree; scientific focus preferred

  • At least 3-5 years of EMA (or equivalent authority) related validation experience

  • Good knowledge of GMPs, 21CFR Part 11, USP 1058 – and other relevant industry regulations and guidance

  • Strong interpersonal skills and demonstrated ability work independently

  • Organized and task oriented

  • Excellent written and oral communication skills – especially on technical topics

  • Self-directed and motivated individual who is able to operate in a rapidly changing business environment

  • Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints

  • Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project

  • Ability to build consensus among team of stakeholders

  • Excellent critical thinking/analytical and problem-solving skills

  • Experience with a multitude of laboratory equipment a plus

  • German & English language skills

Work Conditions:

  • Lab Environment (may need to follow Personal Protective Equipment and Safety Polices);

  • Office Environment

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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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