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Validation Lead

Company: Thermo Fisher Scientific
Location: Olathe
Posted on: August 14, 2019

Job Description:

Job DescriptionWhen you join us at Thermo Fisher Scientific, you ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?

The Validation Lead will develop protocols, execute validation activities, compile results, and write reports. This position requires good documentation skills and attention to detail. The Validation lead should be able to process incoming requests from internal and external customers, then determine how to effectively confirm equipment and processes are acceptable for use.

What will you do?
Implement and maintain the Validation Master Plan for the site.Ensure Validation processes are in compliance with 21CFR part 820, ISO 13485, and other medical device industry standards.Support Regulatory and Customer Audits as the Validation subject matter expert.Support continuous improvement activities and the transition to a Lean Manufacturing Environment.Provide input to cross-functional teams to improve processes.Partner with Engineering to establish equipment parameters that can be validated and sustained.Apply analytical skills to identify issues, find solutions, and attain goals.Maintain Validation team metrics to ensure service level is maintained for internal customers.Perform periodic review of validation results to ensure continuous process control. Analyze data to identify any trends that need to be investigated.How will you get here?:Bachelor s Degree in a science, engineering or related field3 to 5 or more years of Validation experience in a regulated environment such as medical device, pharmaceutical, or biotechnology is preferred Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) is preferredBackground in Medical device, GMP, EU Regulation or ISO 13485 is preferred Data analysis skills and ability to utilize computer programs to analyze data to drive decisions is preferred Experienced in audit preparation, communication with auditors, and formulation of audit response is preferredMust be a self-starter who can take general concepts and direction and produce desirable resultsAbility to prioritize multiple tasks and function effectively.Demonstrated ability to work effectively as a member of a cross-functional team.Strong working knowledge of various computer software, such as Excel, Mini-tab is preferredExperienced with lean manufacturing tools and practices is preferred Ability to perform independently and determine technical objectives and solutions to complex problems.Excellent oral and written communication skills.Strong leadership skills with the ability to influence and lead.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 If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, 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 status. Associated topics: biopharma, dietician, food, industrial hygienist, nutrition, pharmaceutical, pharmacology, physiologist, protein, therapy Associated topics: biopharma, dietician, food, industrial hygienist, nutrition, pharmaceutical, pharmacology, physiologist, protein, therapy Associated topics: biopharma, dietician, food, industrial hygienist, nutrition, pharmaceutical, pharmacology, physiologist, protein, therapy

Keywords: Thermo Fisher Scientific, Olathe , Validation Lead, Other , Olathe, Kansas

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