|Staff Electro-Mechanical Automation Engineer|
Company: Otsuka Pharmaceuticals
Location: Hayward, CA
Employment Type: Full Time
Date Posted: 05/18/2021
Expire Date: 06/18/2021
Job Categories: Biotechnology and Pharmaceutical
Staff Electro-Mechanical Automation Engineer |
Otsuka America Pharmaceutical is seeking a highly motivated Staff-Level Electro-Mechanical Automation Engineer skilled in integrating systems and automated tool development. This person will be an integral team member within the engineering group that will use their vast experience in, designing, developing, improving, and supporting next-generation automated equipment for the high-volume manufacture of Otsuka’s novel ingestible sensor device. This is an exciting opportunity to shape the way in which ingestible sensors are delivered to the world, and we are looking for a candidate that is innovative, data-driven, compliance-focused, and who will be responsible for an array of processes across semiconductor, medical device, and pharmaceutical equipment and processes. The ability to develop creative solutions, and then prioritize and thoroughly execute among many deliverables is essential to success.
* Drive the electrical and mechanical design and implementation of next-generation, high-volume test and production equipment for ingestible sensor fabrication, integrating elements of semiconductor, medical device, pharmaceutical, and web/roll-to-roll based continuous manufacturing
* Identify potential vulnerabilities and opportunities for process improvements; collect, analyze, and document data supporting these findings; draft project proposals to address the findings citing benefits, risks, and ROI
* Work with and manage external vendors and systems-integration/automation houses in the delivery of automated manufacturing and test systems, including technical design review (hardware/software/schematics), acceptance testing, and in-house qualification.
* Draft and execute design control documentation including mechanical drawings, requirements, specifications, process validations, and risk management documents consistent with internal SOPs and FDA 21 CFR part 820 requirements
* Drive root cause analysis and corrective/preventive action projects cross-functionally in support of the Quality Management System
* Ensure new processes and equipment integrate seamlessly into the ingestible product pipeline, including training of operators and establishing of monitoring specifications/SPC
* Interface with cross-functional teams and upper management to clearly communicate direction and priorities to the team.
* Contribute ideas to or generate Intellectual Property submissions
* The ability to lead a project to produce successful outcomes
* A rock-solid work ethic and commitment to the team
* Background in electro-mechanical systems, systems integration, or related area.
* Experience with complex, high-volume equipment and process design and development, integrating mechanical, electrical, and software elements to consistently fabricate conforming product
* Proficiency troubleshooting complex, interdependent processes and systems using data analysis and statistical process control (SPC) to drive decision-making
* The ability to thoroughly document all experiments and findings; IQ/OQ/PQ & Process Validations
* Steadiness to work under pressure and to tight timelines
* The ability to interface with vendors and suppliers in a manner consistent with Otsuka’s goals
* The capacity to prioritize a list of responsibilities and projects which may often change to best meet the needs of the production line
* Integrity and patience needed to ensure all regulatory requirements are met each and every time; and the sense of responsibility to highlight and alert management when these requirements are not met
* Hands-on experience with automated production tools including pick and place, dispensing systems, punch/die mechanisms, machine vision systems, and continuous web systems
* Excellent, detail-oriented verbal and written communication skills
* Ability to read, analyze, and interpret complex documents. Ability to write manufacturing and other documents effectively.
* Ability to work both independently and collaboratively with cross-functional teams.
* Ability to work in a multi-cultural environment.
* CAD experience: Solidworks preferred
* Software/(Labview or Measurement Studios) programming experience a plus
Education / Experience
* B.S. in electrical, mechanical engineering or related field, M.S. a plus
* 10+ years development and implementation of electro-mechanical, automated platforms
* Experience in a regulated environment desired
* While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms; talk and hear. The employee is occasionally required to stand and walk. The employee may occasionally lift and/or move up to 10 pounds.