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Engineer I, Validation

Company: Thermo Fisher Scientific
Location: Greenville
Posted on: February 15, 2020

Job Description:

How will you make an impact?

With 70,000 extraordinary minds on our global team, each one of us at Thermo Fisher has an important story to tell. Whether we?re helping customers to fight disease, making sure our air is clean, or solving cold cases, our stories involve thousands of important projects that improve millions of lives. Our dedicated sales professionals are laser focused on delivering our customer value proposition?accelerating innovation and enhancing productivity. With talented managers and inspiring coworkers to support you, you?ll find the resources and opportunities to make significant contributions to the world.

Summary: Provides direct quality support (e.g. compliance, regulatory assessment, validation) to the business unit, clients and corporate management. Performs quality functions to ensure accurate and timely completion for activities and projects of low complexity with routine decision making required.

Responsibilities

  • Plans, organizes, executes and tracks multiple tasks of low to moderate complexity to ensure timely completion of deliverables related to key quality functions.
  • Analyzes data for routine validation and production documentation to determine acceptability, identifies deviations and make appropriate notification.
  • Approves routine validation and production documentation w/o deviations.
  • Prepares documents and reports; gain multidisciplinary consensus with some degree of independence.
  • Maintains and uses database systems.
  • Performs Good Manufacturing Practices (GMP) audits and quality engineering activities related to process improvement.
  • Prepares, retrieves and reviews documentation for customer and regulatory audits. Assists with presentation of data during customer and regulatory audits.
  • Assesses impact of changes of moderate complexity.
  • Prepares documents for records archival.
  • Assists with training in area of expertise.
  • Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.
  • Complies with all job-related safety and other training requirements.
  • Performs other duties as assigned.Education & Experience
  • Bachelor?s degree in a physical or biological science or production related discipline is required.
  • Two years of relevant experience in Life Science, Chemistry, Biology, Engineering, Biomedical, or IT is preferred.Equivalency
  • Equivalent combinations of education, training, and relevant work experience may be considered.Competencies
  • Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable.
  • Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented.
  • Effective time management and prioritization skills.
  • Requires discretion and independent judgment.
  • Highly effective verbal and written communication skills.
  • Proficiency in Microsoft Suite (Word, Excel, PowerPoint).
  • Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems.
  • Proficient in performing activities within at least one Key Quality Function with minimum direction.
  • Key Quality Functions include: Lab Services, Validation, Batch Disposition, Compliance, Document Management, Customer Relations, and Quality Engineering. Outstanding attention to detail and organizational skills. Selfstarter, mature, independent and dependable.Physical Requirements
  • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds and occasionally pushing or pulling more than 100 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Keywords: Thermo Fisher Scientific, Greenville , Engineer I, Validation, Engineering , Greenville, North Carolina

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