Process Engineer II, Tech Transfer Specialist, Lucerne
Hybrid: 2 days home office
Duration: 1 year and 6 months
The Technology Transfer Specialist will be a member of the Manufacturing Operations team, reporting to the Technology Transfer Lead. The successful candidate will be responsible for supporting New Product Introduction while also acting as a key contributor to the evolving site tech transfer strategy. The Technology Transfer Specialist role will be a Change Champion within the organization and site, bringing about new products, digitization, and ways of working.
Responsibilities and activities can be tailored to the successful candidate's availability and career plan and would primarily entail, but are not limited to:
1. Support the development of the tech transfer program.
2. Collaborate with the team and stakeholders to deliver GMP documents related to tech transfer, such as risk assessments, change controls, batch records, sampling plans, and Bills of Material.
3. Maintain and feed information delivered from Development in different digital tools such as COMET, SAP, MES, and DeltaV.
4. Manage new program introduction schedules to ensure tasks are executed on schedule and right-first-time.
5. Contribute/support in various teams as a Tech Transfer representative.
6. Manage small projects with moderate resource requirements, risk, and/or complexity.
7. Support the development of process descriptions, process models, facility fits, and other tech transfer-related documents for continuous and fed-batch processes.
8. Support the design and implementation of best practices in tech transfer.
9. Assist in the development of future breakthrough business solutions to reduce overall effort and risk, optimizing these to make way for rapid product launch, progressing the team towards “one-click” tech transfer.
10. Provide feedback and propose opportunities for optimization to current tech transfer processes to incorporate lessons learned.
11. Write and maintain BOMs (Bill of Materials) and EBRs (Electronic Batch Records), gBMR (MES), and SOPs/WIs.
Candidate's Requirements:
1. Minimum of 5 years work experience in the pharmaceutical or biotech industry.
2. Familiarity with unit operations for mAb manufacturing.
3. Basic knowledge of project management.
4. Competent in issuing and transcribing information into documents required for manufacturing such as BOMs, Batch Sheets, and DeltaV.
5. Competency in the use of automated/digital systems such as DeltaV, MES, eVal, and SAP COMET.
6. Working knowledge of GMP regulations.
7. Understanding of the general principles of New Product Introduction.
8. Preferably has managed a small project with a cross-functional group.
#J-18808-Ljbffr