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Junior Validation Engineer
Ref No.: 18-12786
Location: South Plainfield, New Jersey
Start Date: 10/01/2018
Job Duties, Responsibilities, Qualifications, and Requirements
Job Summary The Validation Engineer will evaluate and validate the equipment process and procedures used in the development and production of products. They will ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products. They will work with the validation lifecyle for equipment, facilities and processes including automation.
The Validation Engineer needs to be well versed with industry standards and regulatory guidelines and will execute evaluations, qualifications and validations according to and within these requirements.
Essential Duties And Responsibilities
  • Establish validation standards, for components, facilities, equipment, processes, automation, computer systems validation, and cleaning validation.
  • Develop testing protocols, and specifications (URS, Design Spec, Funtional Spec, Component Specs, etc.)
  • Validation testing and documentaton of test results including protocol execution (IQ, OQ, PQ, PV, CSV)
  • Design and execute temperature mapping studies.
  • Coordinate with other personnel or departments who will be affected by validation Activities.
  • Other duties include maintenance of testing equipment and overseeing the inventory of validation supplies.
  • Participating in teams to help make necessary improvements and/or changes to equipment/process related issues.
  • Ensuring quality by design (QbD) is a governing principle.
  • Applying good manufacturing practices and observing that they are being adhered to.
  • Active engagement with quality risk management processes.
Education and/or Experience Requires a university degree in science/engineering
Minimum of 2+ years of experience working in GMP manufacturing, FDA regulated companies, biologics and aseptic processes
Other Duties Other special projects and/or duties may be assigned by Management related to establishing and maintaining quality.
Supervisory Responsibilities None at this time
Language, Mathematical, and/or Reasoning Ability
  • Proven technical writing skills for validation protocols and reports.
  • Sound mathematical and technical skills.
  • Good investigative and problem-solving skills with excellent attention to detail.
  • Ability to think logically and methodically.
  • Good interpersonal skills and organizational skills. • Excellent verbal and written communication skills.
  • Decision making ability coupled with the ability to work independently and proactively.
  • Experience with six sigma, quality by design and quality risk management
  • Knowledge of statistical packages and Microsoft Office systems normally required.
Physical Demands While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
The employee may frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
Additionally, in the performance of the duties of this job, the employee may be required to travel drive a motor vehicle, communicate using telephone and e-mail.
The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations will be made to enable individuals to perform these functions.