Process Engineer Bio Tech Chemistry Jobs Vacancy in Advanced Sterilization Products Irvine
Advanced Sterilization Products Irvine urgently required following position for Process Engineer Bio Tech Chemistry. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Process Engineer Bio Tech Chemistry Jobs Vacancy in Advanced Sterilization Products Irvine Jobs Details:
Your Impact The Sr. Process Engineer is responsible for the development, improvement, validation, and support of semi-automated/fully automated manufacturing processes for production of biochemical products. Scope of responsibility included specifying, procuring, qualifying, troubleshooting, and maintaining equipment needed for processes for mixing, dispensing, and/or packaging biochemical components and/or products. May also be responsible for introducing new manufacturing technologies to support existing manufacturing processes and equipment; addresses daily technical issues and challenges in production and operations. May lead and/or support technology transfers to international or external manufacturing plants. Initiate continuous improvement opportunities utilizing methodologies; such as Lean/Six Sigma, DFM, SPC, etc. Follows domestic and international regulatory standards (e.g., GMP and ISO 13485).
Here’s where you’ll demonstrate your competencies:
Develop process windows/limits for manual and automated production processes;
Perform process validations as required, IQ/OQ/PQ; generate protocols and test reports;
Respond to and solve daily technical issues in Irvine manufacturing;
Disposition Non-conforming materials, determine root cause, and implement corrective action;
Act as technical liaison between R&D Engineering and Manufacturing,
Design, develop, implement, and improve manufacturing processes and equipment
Introduce best in class manufacturing technologies to Irvine operations
Create user-friendly, pictorial based manufacturing procedures with users in mind
Train lab technicians, and manufacturing operators on processes and procedures
Develop, implement, and support Lean processes in production and throughout operations;
Lead/support continuous improvement projects and initiatives;
Troubleshoot production line issues and customer complaints related to yield, quality, and throughput. Implement the appropriate robust containments and corrective actions on identification of root cause.
Develop Process Failure Mode and Effects Analyses;
Support supplier qualifications and assist in new supplier selection process;
Continuously research, learn, and recommend best practices for world-class manufacturing;
Maintain training records and always follow operating procedures; Our Needs Here’s what we’ll need from you:
B.S./M.S./PhD in Engineering discipline, Chemical Engineering, Biochemical Engineering, Bioengineering, Bio-Medical, or MS/PhD in relevant scientific field with at least 4 years of experience in manufacturing, process development and characterization, process design and scale-up, improvement and validation.
Experience with processing, dispensing, and packaging of biochemical products
Experience working in bio-chemical laboratory and with general lab equipment
Experience with Process Validation (IQ/OQ/PQ) and able to generate protocols and test reports
Experience and ability to troubleshoot simple to complex manufacturing process issues
Excellent conceptual, analytical, and problem-solving ability
Experienced and skilled with data analysis including the use of statistical tools such as Minitab
Excellent communication skills, both verbal and written, and the ability to effectively interface within a cross-functional teams.
Skilled with CAD modeling software such as SolidWorks
Experience working in an ISO13485, GMP, or FDA regulated environment is desirable.
Experience with continuous improvement methodologies (ie, Lean, Six Sigma, OEE, ) Fortive is a global family of more than 20 industry-leading industrial growth and technology companies, united by a shared purpose: to make the world stronger, safer, and more effective by providing essential technology for the people who accelerate progress. Here, you get the excitement of a “startup” with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth. There’s no limit to what you can learn, or the impact you can make: for you, for us, for growth. We’re currently building our team of leaders for our Advanced Sterilization Products organization. Be part of an industry-leading company in healthcare-associated infections (HAIs) prevention technology, dedicated to creating the safest possible environments for patients and their families, healthcare workers, providers, and communities. Add your voice and talents to our extraordinary team and help us in our mission to make healthcare safer for everyone. "The company in which you have expressed employment interest is a subsidiary or affiliate of Fortive Corporation. The subsidiary or affiliate is referred to as a ""Fortive Company."" Fortive Corporation and all Fortive Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. The ""EEO is the Law"" poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1-866-272-5573 or e-mail email@example.com to request accommodation."