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Job Description
As part of the Thermo Fisher Scientific team, you’ll 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 world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Excellent Benefits Package
Review our company’s Total Rewards (https://jobs.thermofisher.com/global/en/total-rewards)
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Holidays
401K Company Match up to 6%
Tuition Reimbursement – eligible after 90 days!
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Career Advancement Opportunities
Location/Division Specific Information
Now is an exciting time to join our Nashville Manufacturing & Distribution team, a team dedicated to ensuring our customers receive the products they need to achieve their scientific goals – quickly, reliably, and safely. If you believe in working the right way for the right reason join our growing team today!
How will you make an impact?
As a Senior member of the Quality Engineering Team, the Quality Engineer III is responsible for ensuring compliance of all qualifications and re-qualification on Equipment and software systems within the Single Use Technologies business. These best in class systems are used to develop and commercially manufacture biopharmaceutical medicines that are used to treat diseases and improve the quality of life of patients.
What will you do?
A Quality Engineer III is responsible for implementing and maintaining the Thermo Fisher processes and procedures used to validate customer systems in a scalable, efficient manner. Additionally, this individual is responsible for leading the validation initiative of large and/or highly customized systems which includes deliverable definition, schedule creation/alignment, protocol development/execution, discrepancy management, and project close-out. This role will also lead CAPA investigations for internal quality issues and customer complaints.
The role demands a solid technical background across a variety of scientific fields and fundamentals on Validation Lifecycle which includes Master Validation Planning (MVP), Change Control Management, Risk Assessments, User Requirement Specifications (URS), Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
Responsibilities Include:
Development and maintenance of Master Validation Master Plan for site
Participate in technical aspects of equipment and software validation at the site, including Equipment Qualifications and re-qualifications
Support the validation function by assisting with validation documentation, executing qualification protocols and compiling data
Lead CAPA investigations
Lead multi-functional team members supporting the Customer Complaint Process
Execute Risk and Impact Assessments
Interact directly with customers and internal groups
Drive product and process changes to improve product quality
How will you get here?
Bachelor’s degree in Engineering field or 5 years direct Quality Engineering/Validation experience
Minimum 5 years of validation experience preferred
5 years of hands-on experience leading validation projects which includes developing, executing, and closing out of FAT, SAT, and IQ/OQ/PQ protocols
Experience working in a regulated environment (e.g. ISO 13485:2016, 21 CFR 820, MDSAP)
Knowledge, Skills, Abilities
Good understanding of cGMP, GDP, and ISO 13485:2016 and 21 CFR 820) requirements
Innovative thinking and problem-solving skills (root cause analysis, CAPA)
Attention to detail and ability to identify and remediate compliance issues
Highly effective verbal and written skills
Self-motivated, proactive, and capable of adhering to strict deadlines
Ability to work well under pressure and multi-task
Proven knowledge of Quality Management System tools
Understanding of plastics- materials, properties, manufacturing processes, and product assembly.
Excellent interpersonal, organizational, and influencing skills
Proficient with Microsoft tools; Word, Excel, Power Point, Visio, Teams
ASQ certification is desired
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.