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Validation & Compliance Engineer

Hamilton, NJ 08611

Posted: 05/31/2023 Employment Type: Contract Job Category: Engineering Job Number: 567298 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 40-58.07/hr **salary will be commensurate with experience 

Job Description: 

  • 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
  • Open up Change Controls is TrackWise
  • Create and update and route SDLC documents in MIDAS
  • Execution of SDLC documents on site
  • Route executed and reviewed Acceptance Testing and Change Control Test Plans
  • Translate technical information and requirements into qualification/validation test design
  • Contribute to the overall growth of compliance business

Basic Qualifications:
  • Bachelors Degree; scientific background
  • At least 5+ years of pharmaceutical of FDA related validation experience

Preferred Skill & 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

Other Requirements:
  • Must be able to remains in a stationary position more than 50% of the time
  • The person in this position needs to occasionally move inside and outside labs and follow Personal Protective Equipment and Safety Polices
  • Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
  • Occasionally move or lift up to 25 pounds
  • Specific vision abilities required by this position include without limitation, the ability to observe details at close range (within a few feet of the instrument), distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
  • Regularly operates a computer and other office machinery, such as a calculator, copy machine, and computer printer
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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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