This position will work closely with senior members of Technology Transfer, as well as Manufacturing, Engineering, Procurement, and the East Walpole Operations work centers as needed. Specific responsibility is to utilize project management skill sets to support and facilitate the transfer of ADVIA Centaur Immunoassays to our new China manufacturing site.
Specific activities will include:
Ownership of tasks assigned via assay Wave transfer team, Subject Matter Expert (SME) and/or Core teams
Participates in Process Review and Process Risk Assessment
Preparation of new product BOMs and Routings
Preparation of Standard Product Costs
Process ECOs to create and release new SMNs, BOMs and Routings and new or revised labeling artwork
Generation and review of new manufacturing, QC, material specifications, and other general documents.
Tracking and communicating work-load progress to management and team members on a regular and productive basis
Assist with training and Transfer of Tech Transfer responsibilities to China personnel
Support new product verification manufacturing and test method validation/transfer activities
Support of CFDA submissions as directed
Support risk management and design history files activities
Support other activities within the SME element teams (Product Technical Requirements, Product Performance Evaluation, design history files, clinical trials, and type testing)
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, budget, risk, change, and opportunity and resource management activities). Assists with technical review of system design and documentation. Assists in continuous improvement activities.
BS/BA in scientific or engineering related discipline, 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 related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable.
Preferred Knowledge/Skills, Education, and Experience
Experience with SAP/PLM, BOMs & routings, and ECO & CAPA systems is desired as well as familiarity with design control, verification/validation requirements, GMP and regulatory requirements.
Project Management Professional (PMP) certification is a plus.
Prior experience with the Advia Centaur product line is a plus. Fluent in Chinese-Mandarin is a plus
Key Working Relationships:
Primarily intra-organizational contacts and some external contacts.
Offer of employment with Siemens is conditioned upon the successful completion of a background check and drug screen, subject to applicable laws and regulations.