Quality Engineer, QA Validation
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Job Location:
Greenville, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our QA Validation team at Thermo Fisher Scientific where youll contribute to global healthcare and scientific advancement. As a Staff Validation Engineer youll lead validation activities for critical systems equipment and processes that enable the development and manufacturing of therapies.
Working in a GMP environment youll develop and implement comprehensive validation strategies aligned with regulatory requirements and corporate standards. Youll collaborate with cross-functional teams to ensure the successful qualification of facilities utilities manufacturing equipment and computerized systems throughout their lifecycle.
Your expertise will be vital in maintaining compliance driving continuous improvement and serving as a technical subject matter expert during audits and investigations. Youll have opportunities to mentor team members while working on diverse projects ranging from new product introductions to complex system validations.
REQUIREMENTS:
5 or more years of medical device experience
Expert knowledge of cGMP regulations GAMP 5 21 CFR Part 11 and international regulatory requirements
Strong experience with validation lifecycle documentation including risk assessments validation plans IQ/OQ/PQ protocols and summary reports
Demonstrated expertise in computerized system validation and data integrity requirements
Experience with manufacturing equipment utilities and facility qualification
Proven project management skills and ability to lead multiple concurrent validation projects
Strong analytical and problem-solving capabilities
Excellence in technical writing and documentation
Strong communication and interpersonal skills
Ability to influence and coordinate activities across multiple departments
Proficiency with validation tools and standard office software
Experience mentoring validation staff
Physical ability to work in both office and manufacturing environments
EDUCATION:
Advanced Degree plus 6 years of experience or Bachelors Degree plus 8 years of experience in validation experience in pharmaceutical/biotech manufacturing or related GMP environment
Preferred Fields of Study: Engineering Science Biotechnology or related technical field
Required Experience:
IC
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
