Define, lead and or overtake manufacturing process and inspection related validation activities. Implement and maintain manufacturing processes and inspection methods through work instructions and process flows definition.
Responsibilities & Duties
- Support internal projects with manufacturing engineering project leaders.
- Support the implementation of new products in our current production lines.
- Support the definition of new process flows for existing or new products.
- Support the transfer of products production between sites.
- Support CAPAs.
- Define manufacturing processes, equipment, tooling, fixturing, and methods.
- Define inspection methods and contribute to their validation.
- Create or support the creation of URS for new assets.
- Contribute to the elaboration of business cases.
- Define, write, review and update manufacturing documentation like:
- Manufacturing flowcharts and process information
- Production risks analysis
- Work instructions
- Inspection sheets
- Define, write, review, update documentation and perform activities like:
- Validation assessments/Validation plans
- FAT&SAT protocols
- IQ, OQ, PQ protocols and reports
- Compliance analysis
- Test method validation
- Final inspection reports
- Process risk management
- Engineering studies
- Process monitoring
- FIR for registration
- Biocompatibility assessments
- Manage in ERP/MRP (SAP) product and process information like:
- Master data
- Store and maintain information/documents in PLM system.
- Initiate and manage change management operations (DCR/DCO).
- Maintain our CAQ system.
- Interface with our customer, suppliers, other Jabil sites and internal stakeholder on technical and organization issues.
- Actively seek opportunities for process improvement.
- Accountable to the execution on time and in the required quality of the requested activities.
- Maintain a structured and reliable activities scheduling (workload).
- Validation experience in a regulated medical business.
- Experience of manufacturing processes related to CNC machining.
- Experience in inspection methods.
- Able to interpret correctly customer requirements.
- Experience of medical implants manufacturing.
- Experience of validation processes in a highly regulated business.
- Ability to effectively present information and support all stakeholders.
- Adhere to all site safety and health rules and regulations.
- Flexible, resilient, able to work in a team, proactive and analytic thinking.
- Good communication and presentation skills.
- Fluent German.
- Proficient in English.
Education & Experience Requirements
- Bachelor’s degree or Associates degree + 2 years related experience preferred.
- 2+ years’ experience of validation in a medical regulated business (implants preferred).
- 2+ years of manufacturing engineering experience in machining environment.
- Proficient in MS Word, Excel, PPT.
- SAP knowledges.
If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or by calling 1.727.803.7515 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.