The Sr. Biomedical Engineer/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 Humacyte 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
- Masters in Biomedical, Mechanical, Chemical Engineering or similar field.
- Project Management Certification (PMP)
- Six Sigma
- Solid Works Training
- 7+ years’ experience in bioprocessing or engineering
- Experience operationalizing a cellular biologic (BLA) product.
- A background in FDA regulated products/processes (tissue banking, medical device or pharmaceutical) or other regulated environment.
For consideration you must apply online, submit a current resume and meet the minimum requirements. All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-0213.
Equal Opportunity Employer/Veterans/Disability
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