Job Information
ThermoFisher Scientific Validation Specialist in Lenexa, Kansas
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
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.
Division/Location Specific Information
The Microbiology Division provides solutions and workflow for food, clinical, and pharmaceutical environments. The markets we serve include food manufactures and labs, clinical and healthcare, pharma, and biotech. Our Lenexa Site has over 300+ employees, it manufactures culture media and other microbiological diagnostic products serving customers in the pharmaceutical, food, and clinical laboratories.
Listen to one of our colleagues : https://www.youtube.com/watch?v=klAVrUJqfVc
Find out more about Thermo Fisher : https://www.youtube.com/watch?v=zPVv85C6XSE
Some of the products we make at the site: Dehydrated Culture Media (https://www.thermofisher.com/uk/en/home/industrial/microbiology/microbial-culture/dehydrated-culture-media-products.html)
Find out more about the site: https://youtu.be/T5Ba8_mejfI
Discover Impactful Work:
As a part of the validation team, you will support the validation & qualification of culture media and other microbiological diagnostic products to ensure they meet customer regulatory requirements. This role provides the opportunity to grow within the quality team as a technical expert or people leader as well as other opportunities across the Thermo Fisher organization.
A Day in the Life:
Complete Validation studies in compliance with 21CFR part 820, ISO 13485, and other medical device industry standards.
Implement the Validation Master Plan (VMP) for assigned area. Perform new qualifications and routine requalification’s according to the VMP.
Collect samples and analyze data to evaluate equipment and process performance.
Set, incubate, and read microbial media test results. (Including bacterial indicators (BI), media fills, and utilities)
Perform investigations when abnormal results are found.
Support process investigations with validation data as needed.
Write reports and protocols to support qualification of new equipment and requalification.
Support Regulatory and Customer Audits.
Support continuous improvement activities and the transition to a Lean Manufacturing Environment.
Provide input to cross-functional teams to improve processes.
Partner with Engineering on installation and qualification of new equipment.
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Keys to Success:
Education
- Bachelor’s Degree in a science, engineering, or related field required.
Experience
1 -2 years of Validation experience in a regulated environment required.
Experience with lean manufacturing tools and practices.
Knowledge, Skills, Abilities
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).
Background in Medical device, GMP, EU Regulation or ISO 13485.
Data analysis skills and ability to use computer programs to analyze data to drive decisions.
Ability to prioritize multiple tasks and function effectively.
Proven ability to work effectively as a member of a cross-functional team.
Solid understanding of various computer software, such as Excel, Mini-tab.
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
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.