Provide technical manufacturing support to Operations and Engineering.
How you will make an Impact:
- Execute validation protocols and Ramp up & stability tests (following protocols) to develop findings for the validation and improvement of manufacturing equipment.
- Collaborate with the Engineering team on equipment investigations, testing, and root cause analysis .
- Compile documentation for archives to ensure appropriate documentation for development work, including ECRs, SOPs, drawings, and tooling, for Engineering approval
- Utilize manufacturing & maintenance software systems (e.g., JDE, QMS,PLM, MMS ) to update documentation to their relevant systems
- Perform scheduled preventive maintenance routines for equipment to avoid production line down time
- Check for failures in equipment and perform corrective actions to affected areas that have down time,
- Troubleshoot basic manufacturing equipment
- Other incidental duties
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What You'll Need (Required):
Technical craft trade qualifications in either an Electrical /Mechanical discipline or a Technical Diploma with at least 2 years plus experience in a highly regulated medical/manufacturing industry.
What else we look for (Preferred):
- Good computer skills, including usage of MS Office Suite
- Basic written and verbal communication, interpersonal, and relationship building skills and capable of working in a team.
- Moderate knowledge of equipment installation and validation processes such as FAT's, SAT's, IQ's )
- Moderate knowledge of reading tooling / fixture drawings.
- Moderate experience in dealing with external supply & service vendors and working with Procurement (PO) systems ( Coupa is highly preferred)
- Ability to troubleshoot manufacturing equipment and read equipment technical drawings.
- Good knowledge of routine preventive maintenance and performance of same in a Maintenace Management Systems (Maximo IBM is highly preferred)
- Good knowledge of electrical, mechanical, electronic, pneumatic, and PLC control systems.
- Good Knowledge of and adherence to industrial Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
- Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.
- Strict attention to detail and adherence to SOP's.
- Must be able to work under limited supervision to manage their work load.
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.