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Thermo Fisher Scientific · 19 hours ago

Engineer II, Validation

Greenville, North Carolina, USA

Full-time

Onsite

Entry, Mid Level

2+ years exp

Thermo Fisher Scientific is a global leader in healthcare and scientific advancement, and they are seeking a Validation Engineer II. In this role, you'll be responsible for ensuring compliance, quality, and operational excellence through comprehensive validation activities in pharmaceutical manufacturing and laboratory operations.

Research

No H1B

Responsibilities

Ensuring compliance, quality, and operational excellence across our facilities through comprehensive validation activities

Maintain high standards in pharmaceutical manufacturing, laboratory operations, and quality control

Qualification

Validation experienceIQ/OQ/PQ protocolsCGMP knowledgeAutomation systemsQuality management systemsData analysisTechnical writingStatistical analysisMicrosoft OfficeCommunication skillsInterpersonal skillsProject management

Required

Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical field

2 years of validation experience in a GMP/regulated environment

Experience with IQ/OQ/PQ protocols and execution

Experience managing validation projects independently

Experience with automation systems and computer system validation

Experience with quality management systems and documentation

Comprehensive knowledge of cGMP, FDA regulations, and industry standards (ISO, GAMP5)

Strong technical writing skills for validation documentation

Proficiency in risk assessment and gap analysis

Strong data analysis and problem-solving capabilities

Clear verbal and written communication skills

Proficient in Microsoft Office applications

Knowledge of calibration and metrology principles

Ability to work in cleanroom environments when required

Effective interpersonal skills for team collaboration

Ability to manage multiple projects

Knowledge of statistical analysis and process control methods

Consistent record of completing projects on schedule in a deadline-oriented environment

Preferred

Advanced degree preferred

Company

Thermo Fisher Scientific

Glassdoor3.6

The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.

Écublens, Vaud, CH

10001+ employees

https://www.thermofisher.com/de/de/home/industrial/spectroscopy-elemental-isotope-analysis/oes-xrd-xrf-analysis/optical-emission-spectrometry-oes.html

Funding

Current Stage

Late Stage

Leadership Team

Heather Stewart

HR Business Partner - Global Enterprise Services

Laura Green

Associate Human Resources Business Partner

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