Job Description
One of our large medical device companies is seeking a Validation Engineer to join their team. The Validation Engineer will be a key contributor to validating a very high visibility raw material implementation project at the site. They will successfully lead and support the following activities with their cross-functional
and Engineering team partners:
• Plans, conducts and manages multiple engineering and material
implementation/validation projects across various manufacturing platforms.
• Develops, implements and qualifies material, equipment and/or process
enhancements/changes that will aid in qualification of the highest priority material
implementation
• Strong analytical approach to problem solving to deliver innovative solutions.
• Project Management to qualify materials, processes, equipment, systems and/or
equipment
• Root cause analysis for problem solving and improvement of manufacturing
equipment, processes, and systems.
• Responsible for all associated project documentation to include those that
involve change management and quality system.
• Work with agility to solve unplanned downtime or excessive rejects during
protocols to develop solutions to successfully complete validations and testing.
• Performs justification of capital and expense projects for project development of a medium complexity. This position pays $25-30/hour depending on experience.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
Bachelors degree in Engineering (mechanical, electrical, etc)
• Experience with working in submitting test documentation and managing change
requests.
• Experience working with nonconformance investigations and CAPAs
• Experience working in a regulated industry environment
Nice to Have Skills & Experience
-Experience working with validations and processing technical documents
(DOE/IQ/OQ/PQ)
-Medical Devices industry experience
-Achievement of Six Sigma/Green Belt/Black Belt accreditation is a plus.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.