Thermo Fisher Scientific Validation Engineering Supervisor in Logan, Utah
When you are part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
Logan, Utah - Single Use Technologies
How will you make an impact?
The Supervisor of Validation is responsible for the daily oversight of the Validation team. The Validation Supervisor is responsible for ensuring compliance of all qualifications and re-qualification on Equipment and software systems. The complexity of the work demands a solid technical background across a variety of scientific disciplines and fundamentals on Validation Lifecycle which includes Change Control Management, Risk Assessments, User Requirement Specifications (URS), Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
What will you do?
Participate and lead teams to ensure appropriate alignment of resources to technical challenges and routine operational needs
Responsible to ensure departmental resources are appropriately allocated based on work scope and technical needs
Track and report status on KPIs relevant to Validation activities/responsibilities and ensure commitment to key stakeholders are met in a timely with the highest quality
Participate in Project Teams as they relate to specific projects
Manage technical aspects of equipment and software validation at the site, including Equipment Qualifications and re-qualifications, Periodic Reviews and Validation Master Plans
Responsible for review and approval of SOPs, Validation Protocols and Summary Reports
Other documents that may require periodic review and approval include CAPAs, Change Controls and Maintenance Work Orders
Author/Review/Execute validation protocols and validation summary reports; analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification/recommendations for optimization of process or systems.
Responsible for the validation SOPs
Interfaces with all levels of Thermo Fisher Scientific employees, customers and representatives of regulatory agencies
Audit Support: Ensure site readiness for regulatory agency and customer audits regarding validation activities
Builds a strong working environment that promotes our core values and progresses our culture in a positive manner (healthy cross-functional teamwork)
Capable of leading change in a positive manner
Peer Mentorship/Training: Effectively supervise, develop, and support peer groups and project teams; support cooperation and teamwork, work toward solutions which generally benefit all involved parties; mentor and train peers
Excellent interpersonal and communication skills (oral and written)
How will you get here?
A Bachelor's degree with a minimum of 7 years industry experience, preferably in Biotech, Pharma or Medical Device, and a minimum of 5 years in Validation
Prior Supervisory experience preferred
Experience overseeing validation programs personnel in a fast-paced environment
5 - 7 years' experience in medical device, biotech or pharmaceutical industry in an Engineering, Quality or Regulatory related role.
Must have direct experience with:
Equipment and software validation
Stability and Expiry program
ISO 13485, FDA 21 CFR Part 820 and FDA 21 CFR Part 11
Knowledge, Skills, Abilities
Strong analytical, problem solving, and teamwork skills are required.
Experience at effectively communicating complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvements.
Ability to analyze and process data and draw the appropriate conclusions.
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, in-depth understanding of products and processes
Understanding of plastics materials, properties, manufacturing processes, and product assembly.
Experience prioritizing conflicting demands
Excellent interpersonal, organizational, and influencing skills
Ability to analyze and process data, and draw the appropriate conclusions
Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
Excellent communication, written and presentation skills. Proficient with Microsoft tools; Word, Excel, Power Point, Visio, Teams; MiniTab.
ASQ certification is desired.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
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.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.