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Cook Medical Bloomington, United StatesOverview · The Senior New Product Introduction (NPI) Engineer will bridge Product Development into Manufacturing Engineering, Quality, and Operations. They will be responsible for configuring and optimizing of processes required to manufacture new medical devices. Additionally, ...
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Cook Group Bloomington, United StatesOverview: · The New Product Introduction (NPI) Engineer will bridge Product Development into Manufacturing Engineering, Quality, and Operations. They will be responsible for configuring and optimizing of processes required to manufacture new medical devices. Additionally, identi ...
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Cook Group Bloomington, United StatesOverview: · The Senior New Product Introduction (NPI) Engineer will bridge Product Development into Manufacturing Engineering, Quality, and Operations. They will be responsible for configuring and optimizing of processes required to manufacture new medical devices. Additionally, ...
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Senior Validation Engineer - Bloomington, United States - CAI
Description
We are seeking CQV Engineers with 4-12 years' experience and we can assist with relocation costs.Position Description:
The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation.
These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
Other responsibilities include planning/coordinating work and directing small teams in document development and/or execution.Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent years of experience
4-12 years' experience
in commissioning and/or qualification activities in a regulated industry
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently, while quickly building and nurturing a project team
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Experience in planning / directing C&Q activities a plus
Must have experience in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide.
We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher StandardOur approach is simple; we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:We act with integrity
We serve each other
We serve society
We work for our future
With employee ownership, one person's success is everyone's success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1$87,100 - $123,300 a year
Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace.
We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked to do other duties.CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
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