Duration: 12 months-potential to convert into full time
Works closely with senior members of Technology Transfer, Manufacturing and other functional groups as needed to transfer new and existing products to the manufacturing site in Shanghai, China. Experience with SAP/PLM, BOMs & routings, and ECO systems is desired as well as familiarity with design control and verification/validation requirements. The ideal candidate will have demonstrated leadership skills and some experience with project management.
Specific activities will include:
- Responsible for implementation of new or revised labeling artwork for In Vitro Diagnostics products
- Coordinate Artwork change control workflows for assigned products, markets, and/or vendors
- Process Review and Process Risk Assessment
- Preparation of new product BOMs and Routings
- Process Walpole ECOs to create and release new SMNs, BOMs and Routings and new or revised labeling artwork
- Generation and review of detailed manufacturing procedures
- Authorship of Validation Plans and Reports
- Scheduling and monitoring of new product validation manufacturing events
Job Family Responsibilities:
Assists in the development of project/program plans. Assists in the delivery of routine projects or programs. Assists in routine project/program management activities (defining scheduling, risk, change, and opportunity). Assists with technical review of system design and documentation. Assists in continuous improvement activities.
BS/BA in Chemistry, Biology, Regulatory or related, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
Knowledge and Experience:
- Demonstrates a good grasp of knowledge and principles of field of specialization and applies through successful completion of assignments.
- Successfully applies knowledge of fundamental concepts, practices, and procedures of particular area of specialization.
- Typically up to 2 years of successful experience in the medical device or pharmaceutical industry and successful demonstration of Key Responsibilities and Knowledge as presented above Advanced degree MAY be substituted for experience, where applicable.
- Excellent verbal and written communication skills
- Excellent organization and time management skills
- High attention to detail and proficiency Microsoft office applications
- Verbal/written proficiency in Mandarin is highly desired
Role ideal for fresh college graduates.