Descripción del Trabajo
Provides validation and project support for NPI activities in the Jabil ABQ Packaging Workcell. The successful candidate should bring experience in writing and executing IQ/OQ/PQ protocols in a regulated environment as well as knowledge of project management, configuration management, and change control.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Develop expertise with federal regulations and guidelines including 21 CFR Part 820 and ISO 13485 as applied to packaging and labeling of medical devices.
- Interface with production staff and manufacturing engineers to determine equipment and system requirements for new packaging products and processes.
- Interact with Plant Management, Operations, Quality, Sterilization, and Purchasing to understand requirements, communicate status, and resolve issues.
- Manage and execute projects focused on introducing new packaging products, equipment, and processes.
- Cooperate with strategic collaborators to write and execute validation documents (IQ, OQ, SQ, PQ, PV) that are compliant with applicable global regulations, directives, standards, and guidance requirements.
- Work with enterprise resource systems for project management, configuration management, and change control
- Displays awareness and compliance of Health & Safety issues
- May perform other duties and responsibilities as assigned.
JOB QUALIFICATIONS and KNOWLEDGE REQUIREMENTS
- Requirements for the validation of medical devices, packaging, and labeling in a 21 CFR Part 820 environment.
- Experience working with customers and managing expectations
- Technical writing in a regulated environment
- Advanced PC and communications skills
- Ability to exercise initiative and apply judgement to complete ambiguous tasks
- Strong attention to detail and organizational skills
Education & Experience Requirements
- Technical degree preferred
- 3+ years of experience with validation of manufacturing processes and equipment; preferably in a regulated environment