Kelly Services Biomedical Engineer in Centennial, Colorado
Biomedical Engineer - 87K per year (Direct Hire Position) YOU MUST HAVE 5 YEARS OF ENGINEERING EXPERIENCE DIRECTLY RELATED TO SUPPORT OPERATIONS, VALIDATION OF EQUIPMENT AND ADDRESSING CUSTOMER ISSUES.
The Sr. Engineer, Arteriovenous AV Access will be the technical process engineering expert related to vessel and cell production. This includes managing related projects, developing new equipment, processes and systems. Existing operation equipment/processes/systems will also be supported on a day to day basis, including but not limited to standard bioprocess skills, maintenance of common laboratory equipment, process/product engineering, documentation, equipment validation/verification, specification creation and resolution of production processing issues.
Responsible for partnering with all key stakeholders to ensure deadlines/statuses and desired end results are achieved and communicated in a timely and efficient manner
Essential Duties and Responsibilities:
Responsible for technical troubleshooting of GMP manufacturing issues in clinical study and commercial product manufacturing. Implementation and management of systems that ensure regular and routine calibration, maintenance and repair when equipment malfunctions. Operational coverage in AV Access, on an as needed basis; including routine cell culture and bioreactor processes . Support manufacturing in the form of operational process improvements, oversight of tech transfer of changes recommended by contract manufacturing partner and/or to implement lean manufacturing improvements to existing processes. Provide timely technical support to manufacturing on novel and basic bioprocess equipment, ensuring consistent and reliable operations to include bioreactors, incubators, blood gas analysis, pressure sensing and monitoring, etc. Provide technical support with external vendors who provide GMP raw materials when investigations and changes to raw materials are necessary. Draft and execute process and equipment verification and validations. Provide written technical background/rationale in response to non-conformance events in manufacturing Track, analyze and respond to in-process data tracked in on-going production batches to identify potential manufacturing issues and process drift. Provide feedback to production team as appropriate. Primary interface with process development and engineering teams. Assist process development team in testing prototype equipment for the production of tissue engineered products in bioreactors. Assist with technology transfer to commercial scale. Oversee transition of newly developed methods to manufacturing to maintain compliance with regulatory and quality control requirements. Participates in special projects and support Operations activity on an as needed basis. Participates in financial objectives and performance goals. Adheres to and promotes proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
Bachelor s degree in an Engineering discipline 5 years engineering , directly supporting operations, validation equipment/processes and addressing customer issues Solid analytical, problem solving and innovative skills are required to apply to new methodologies addressing unique and new company challenges. Strong background in aseptic processes Strong understanding of GMP in biotechnology and bioprocessing manufacturing environments Proficiency in Microsoft Applications, specifically Excel, Word and Outlook
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.