Engineer I, Validation
Company: Thermo Fisher Scientific
Posted on: February 15, 2020
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.
- 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
- 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
- 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
- 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
- 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
- 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
Keywords: Thermo Fisher Scientific, Greenville , Engineer I, Validation, Engineering , Greenville, North Carolina
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