Validation Engineer

Job Overview

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  Schedule: Monday – Friday, 8:00 AM – 4:00 PM (includes a 30-minute unpaid lunch)

  
  
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  Location: 100% Onsite (5x/week)

  
  

Job Summary

With direct supervision, the candidate is responsible for the support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech corporate principles, quality policies, standards, and core values. Maintains the company’s right to operate, supply to patients, and cost-effectiveness by actively participating in continuous improvement projects.

Duties

Technical Responsibilities

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  Perform qualification of laboratory equipment in accordance with EQ policies, plans, and procedures.

  
  
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  Coordinate with laboratory personnel to define qualification requirements.

  
  
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  Author, review, and execute equipment qualification protocols.

  
  
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  Coordinate equipment qualification activities w ith vendors and other support g roups.

  
  
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  Identify business, quality, and compliance gaps.

  
  
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  Sign documents for activities as authorized and described by Genentech policies, procedures, and job descriptions.

  
  
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  Perform any other tasks as requested by Senior Management to support QC laboratory operations.

  
  

Job Requirements

Education

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  BS/BA degree (preferably in a relevant scientific discipline).

  
  

Experience (may vary depending on site size/scope)

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  Experience in the pharmaceutical/biopharmaceutical industry, or an equivalent combination of education and experience.

  
  
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  Knowledge of cGMP or equivalent regulations.

  
  
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  Minimum of two years’ experience in Validation or equipment qualification is desired.

  
  
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  Ability to make sound decisions about scheduling and managing priorities.

  
  
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  Flexibility in problem-solving, providing direction, and work hours to meet business objectives.

  
  

Knowledge / Skills / Competencies

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  Possesses strong verbal and written communication skills and the ability to influence at all levels.

  
  
  
  
  
  
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  Capable of building trustful and effective relationships.

  
  
  
  
  
  
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  Able to think strategically and translate strategies into actio nable pl ans.

  
  
  
  
  
  
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  Takes responsibility, drives results, and achieves expected outcomes.

  
  

Work Environment / Physical Demands / Safety Considerations

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  Standard office environment