Associate Process Engineer
3 weeks ago
Position Summary:
As part of the Industrialization department, the Process Engineer will develop and/or manage process improvement projects to support the manufacturing of in vitro diagnostics. Within this role the Process Engineer will be required to interface with Manufacturing, Quality Control, Quality Assurance, R&D, Purchasing, Supply Chain, HSE, and other functions as required, to ensure successful project achievements and to facilitate quality production that meets on-time customer demands. Duties will be carried out as a member of a team committed to Total Quality Management philosophy. Work will be conducted in accordance with GMP and ISO rules and regulations.
Primary Responsibilities:
+ Support and/or manage multiple projects related to the manufacturing of in vitro diagnostics.
+ Guide timelines, adjust expectations, coordinate with colleagues, and collaborate cross-functionally to ensure successful project implementation.
+ Provide subject matter expertise (technical knowledge) when acting as departmental representation on cross-functional teams, as well as, participate and identify improvement opportunities and strategies.
+ Design and conduct statistically valid, scientifically sound feasibility studies and process development projects, and prepare timely written updates and report of these activities.
+ Write and execute validation protocols as required by the change control and validation programs.
+ Analyze process and product performance data to predict/prevent potential failures and aid in solving product/process challenges.
+ Analyze components (materials) to mitigate manufacturing risk and/or cost saving initiatives.
+ Support investigations and implementation of solutions (corrective and preventative actions) to solve manufacturing and product challenges; follow-up on actions to determine their effectiveness and suitability; and, prepare written reports on these activities in a timely fashion.
+ Perform all work in compliance with company quality and safety procedures and standards.
+ Performs other duties as assigned.
Education, Skills, & Experience:
+ Bachelors Degree in Chemical/Bioprocess Engineering, or closely related field.
+ Chemical, Mechanical, or Biomedical engineering preferred but not required
+ Preferred experience related to data management and analysis.
+ Preferred experience in an FDA regulated industry.
-
Associate Process Engineer
3 weeks ago
Durham, North Carolina, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Position Summary:As part of the Industrialization department, the Process Engineer will develop and/or manage process improvement projects to support the manufacturing of in vitro diagnostics. Within this role the Process Engineer will be required to interface with Manufacturing, Quality Control, Quality Assurance, R&D, Purchasing, Supply Chain,...
-
Principal Process Development Engineer
6 days ago
Durham, United States EPM Scientific Full timePrincipal Process Development Engineer Location : RTP, NC Working situation : On-site Level : Principal Engineer Our client, a global leader in eye care, is working to develop life-changing technology that improves patients' lives worldwide. With a commitment to excellence and innovation, we're at the forefront of advancing healthcare solutions. The...
-
Process Sciences Engineer II
14 hours ago
Durham, United States Fujifilm Holdings Corp Full timeMay support technical transfer of client project in and to manufacturing as applicable. Summarizes and report data. Interacts with supervisor and reports results and interpretation of experiments, project deliverables, and process readiness. Supports Science, Engineer, Process Engineer, Product Development, Chemistry, Computer Tech, Manufacturing
-
Senior MSAT/Process Engineer
2 weeks ago
Durham, United States HUMACYTE GLOBAL INC Full timeJob Description Job Description Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular...
-
Senior MSAT/Process Engineer
3 weeks ago
Durham, United States HUMACYTE GLOBAL INC Full timeJob DescriptionJob DescriptionHumacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular...
-
Process/Validation Engineer
1 month ago
Durham, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Validation Planning: Develop and implement validation strategies, including process, equipment, and cleaning validation, in compliance with FDA and international regulatory guidelines. Validation Protocol Design: Create and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and cleaning procedures. Process...
-
Associate III, Quality Engineering
5 days ago
Durham, United States Biogen Full timeAbout the Role. The Quality Engineering (QE) Associate III is responsible for the oversight of key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The QE Associate III will p Quality Engineer, Associate, Engineer, Quality, Equipment, Systems, Technology
-
Senior/ Lead Process Engineer
1 week ago
Durham, United States Elo Life Systems Full timeTHE ROLEReporting to the SVP, Global Manufacturing, Operations and Regulatory, the Senior/Lead Process Engineer will be a key member of the Manufacturing team. This role will be responsible for developing and managing Elo’s pilot studies (bridging with R&D on bench studies) as well as scaling and optimizing ingredient production to meet commercial...
-
Senior/ Lead Process Engineer
1 week ago
Durham, United States Elo Life Systems Full timeTHE ROLEReporting to the SVP, Global Manufacturing, Operations and Regulatory, the Senior/Lead Process Engineer will be a key member of the Manufacturing team. This role will be responsible for developing and managing Elo’s pilot studies (bridging with R&D on bench studies) as well as scaling and optimizing ingredient production to meet commercial...
-
Senior/ Lead Process Engineer
1 week ago
Durham, United States Elo Life Systems Full timeTHE ROLEReporting to the SVP, Global Manufacturing, Operations and Regulatory, the Senior/Lead Process Engineer will be a key member of the Manufacturing team. This role will be responsible for developing and managing Elo’s pilot studies (bridging with R&D on bench studies) as well as scaling and optimizing ingredient production to meet commercial...
-
Wafer Processing Engineer
1 month ago
Durham, United States Micross Components Full timeJob DescriptionJob DescriptionMicross Advanced Interconnect Technology is seeking a knowledgeable, self-motivated physical science or engineering student for an internship with our Process Engineering team. The internship will require extensive hands-on wafer processing in our cleanroom facilities with the successful candidate performing any of the...
-
Wafer Processing Engineer
1 month ago
Durham, United States Micross Full timeSummary: The position will primarily focus on learning and supporting wafer processing steps required to further develop and build IR emitter pixels for the IRSP program area. This includes sputter depositions, reactive sputter depositions, ion milling, RIE, descums, ultrasonic (US) resist strips, microscope inspections, and thin film metrology. The...
-
Associate Sales Engineer
3 weeks ago
Durham, United States Juniper Networks Full timeAt Juniper, we believe the network is the single greatest vehicle for knowledge, understanding, and human advancement the world has ever known. To achieve real outcomes, we know that experience is the most important requirement for networking teams and the people they serve. Delivering an experience-first, AI-Native Network pivots on the creativity and...
-
Postdoctoral Research Associate
3 weeks ago
Durham, United States University System of New Hampshire Full timeThe School of Marine Science and Ocean Engineeringat UNH invites applicants for a Postdoctoral Scholar on engineering transport processes in nearshore environments, beginning June 2024. The scholar will conduct research to evaluate the scaling laws a Research Associate, Doctor, Postdoctoral, Research, Associate, Mechanical, Healthcare, Education
-
Process Engineer
1 week ago
Durham, United States Micross Components Full timeJob DescriptionJob DescriptionSummary:We are seeking a knowledgeable, self-motivated individual for our growing operations team which will support processing in a dynamic production and R&D environment. This position will focus on supporting advanced packaging processing and process development, for, but not limited to, silicon interposer fabrication,...
-
Manufacturing Associate I/II
4 days ago
Durham, United States KBI Biopharma Full timePosition Summary This position operates on a 2-2-3 schedule with the hours of 7:00 am - 7:30 pm. The Manufacturing Associate I/II (Manufacturing Associate) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Manufacturing Associate must follow written,...
-
Senior Manufacturing Associate I/II
4 days ago
Durham, United States KBI Biopharma Full timePosition Summary The Senior Manufacturing Associate I/II is responsible for performing upstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Senior Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good...
-
Environmental Monitoring Associate
4 days ago
Durham, United States Piper Companies Full timePiperCompanies is currently seeking aEnvironmental Monitoring Associate based inDurham, North Carolinafor work at a leading pharmaceutical company. This is a second shift/night time opportunityWednesday to Saturday 4pm to 2:30am Responsibilities of the Environmental Monitoring Associate: Conduct quality walk-throughs of the production, testing and warehouse...
-
Senior Automation Engineer
6 hours ago
Durham, United States Adameservices Full timeJob Title: Senior Automation Engineer Job Type: Hybrid Job Location: Durham, NC Job Description requires the assistance of a Senior Automation engineer to help automate and improve the building, deploy and operation of (NC FAST) Applications. The primary role is to lead Automation effort of infrastructure provisioning, build and deploy activities for NC FAST...
-
Engineering Tech
3 days ago
Durham, United States bioMérieux SA Full timeDescription Position Summary: The Engineering Technician is responsible for the support and troubleshooting of bioMérieux manufacturing, formulation, filling, and packaging equipment systems within the site quality management system processes. Support large and manage small scale Engineering projects at the Durham site.Ensure required Engineering support...