- The scope of work will be primarily focused on the AV TEM JI remediation initiative. The engineer will review, and update AV TEM training guides (includes Job Instructions + Job Breakdown sheets) for products produced in the Temecula facility. This includes (but not limited):
- Review & assess the content of the training guides to ensure it lines up with the manufacturing instructions (MPI)
- Correct for any gap/fixes (i.e. redline/update documents, initiate COs)
- This job will require the engineer to work with line support ME, line supervisors, Operators to ensure there is alignment on changes/corrections to the documents
- This job will require the engineer to go into the production lines to review and verify the manufacturing sequences is aligned with the MPI.
- This job will require the engineer to train trainers on the changes/updates to the documents
- other tasks as assigned
- Experience using MS office applications
- Degree in Engineering
- Experience in manufacturing (hands on)
- Experience in creation and/or modification of manufacturing related document instructions
- English proficient
- Familiar with CO/CR process
- Familiar with redlining documents
- Familiar with internal systems (LHR, viewpoint, sumtotal, blueprint, others)
- Training of production personnel - Worked in a clean room environment
- Worked in medical devices Must be motivated, self starter, organized, and can multitask. Must have good communication skills (verbal and written)
- There is no traveling. Will require some flexibility on hours (to be aligned with production schedule and line support ME hours) Will require to stand for extended periods of time (while in the clean room)
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Manufacturing Engineer - Temecula, United States - Planet Pharma
Description
Job description:
Requirements:
Plus:
Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company's environment to take an effective and proactive leadership role in a specific technical manufacturing discipline. Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks ? tasks that may have multiple inter-coordinating elements. Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required. Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components. Interaction with peers and mentors on the individual?s projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.
Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering. Curriculum trains students in skills required to perform assignments. 0-3 years exp
