Thermo Fisher Scientific Validation Specialist in Lenexa, Kansas
Validation Specialist Job Description:
The Validation Specialist will implement the validation master plan, including qualification and periodic confirmation of manufacturing equipment and processes.
The Validation Specialist will develop protocols, execute validation activities, compile results, and write reports. This position requires good documentation skills and attention to detail.
Execute 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 requalifications 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.
Bachelor's Degree in a science, engineering or related field.
1 -2 years of Validation experience in a regulated environment such as medical device, pharmaceutical, or biotechnology.
3 or more years of Validation experience in a regulated environment such as medical device, pharmaceutical, or biotechnology.
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 utilize computer programs to analyze data to drive decisions.
Ability 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
Experienced with lean manufacturing tools and practices.
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.