Title: Packaging Engineer
• Ensure availability and correctness of packaging documentation for sterile and non-sterile medical devices, in compliance with all valid regulations (ISO, MDR, FDA, etc.)
• Check packaging configurations (Bill of material) and packaging validation documentation (package transit qualification, packaging shelf life) in PLM/ERP systems and verify their correctness
• Perform updates/changes (DCR/DCO) for non-conforming packaging documents and Bill of Materials in the systems (Agile/SAP/Windchill)
• Support Shelf Life activities and create/update shelf life specific documentation for Eu and US
POSITION DUTIES & RESPONSIBILITIES:
•Review and update technical reports, procedures, policies and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements and current technology.
• Establishes and tracks critical milestones, timelines and contingency plans
• Follows up throughout project process to ensure project goals are achieved
• Seeks out continuous improvement opportunities and oversees timely implementation of efficient manufacturing practices.
• Responsible to originate/oversee/assist in the creation & release of change orders (COs) for all packaging related change requests through Agile PLM software.
- Responsible to originate/oversee/assist in the creation & release of change orders (COs) for shelf life related change requests through Agile PLM software.
• Technical understanding (drawings, processes, packaging specifications and materials, validation standards (ISO11607, ISTA3A, ASTM standards for testing…), etc.)
PROFESSIONAL EXPERIENCE REQUIREMENTS:
• At least 4 years’ work experience in an adequate position and regulated industry preferred
• Experience in an Medical Device regulated environment, package qualification or quality eng. department a plus
• Proven exceptional written and oral presentation skills
• Bachelor’s degree in engineering or related discipline, or equivalent and extensive related project experience.
• Certificates in Program/Project Management will enhance candidacy but are not a requirement
• Fluent English
• Strong knowledge and skills in MS Office
• Knowledge and skills in PLM system, ex. Windchill, Agile, Adaptive, SAP will enhance candidacy
Michael Bailey International is acting as an Employment Business in relation to this vacancy.