The manager, manufacturing execution system is responsible for the design, development, documentation, validation, and implementation of the manufacturing execution systems (mes) solution.
provide organization oversight and program management for systems involving the development of mes solutions and work closely with business management, users to define the needs, design solutions.
work with process owners, team members, and system users to establish and enhance business processes with mes solutions through analysis and documentation.
*responsibilities*:
- provide leadership to the site as the point of contact for mes and collaborate with it, quality, supply chain, manufacturing, process development to drive continuous improvements using mes
- provides technical knowledge, expertise and hands-on experience in the maintenance and support of the mes system for business areas.
- provides technical knowledge, expertise and hands-on experience in the development and re-engineering of manufacturing and test documents in order to create the electronic device history record.
- act as plant's mes system manager
- lead engineering projects ensuring that projects are completed on schedule and within budget.
- prepare/review capital & expense forecasts for assigned projects.
prepare capital authorization requests (car).
- report status on assigned projects in various formats to various organizational levels.
- perform process validations on new, transferred, or modified processes for mes implementation.
- ensure compliance to the quality policy in all activities.
- lead teams for mes continuous improvements.
- responsible for communicating business related issues or opportunities to next management level.
*qualifications*
*education*:
- a minimum of a bachelor's degree is required; preferably in engineering, science, or related field
required skills and experience:
- a minimum 8 years of relevant work experience
- knowledge of fda guidelines pertaining to software validation
- ability to be hands on with mes configuration and development
- ability to acheive results within assigned deadlines and able to prioritize multiple tasks within a fast-paced environment
preferred skills and experience:
- experience in a manufacturing environment and/or medical device industry
- project management and influencing skills
- people management experience
- knowledge in 21 cfr part 11 compliance
other:
- this position may require up to 10% travel, both domestic and international
johnson & johnson is an affirmative action and equal opportunity employer.
all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
*primary location*
united states-california-santa clara-5490 great america pkwy
*other locations*
north america-united states-puerto rico, latin america-mexico-chihuahua-juarez, north america-united states
*organization*
auris health, inc. (6267)
*job function*
r&d
*requisition id*
2206061763w