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, to bring about new products, digitization, and ways of working.
Responsibilities: Support the development of the tech transfer program.
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.
Maintain and feed information delivered from Development in different digital tools such as COMET SAP, MES, and DeltaV.
Manage new program introduction schedule to ensure tasks are executed on schedule and right-first time.
Contribute/support in various teams as Tech Transfer representative.
Manage small projects with moderate resource requirements, risk, and/or complexity.
Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
Support design and implementation of best practices in tech transfer.
Assist in the development of future breakthrough business solutions to reduce overall effort, reduce risk, and optimize processes for rapid product launch, progressing the team toward “one-click” tech transfer.
Provide feedback and propose opportunities for optimization to current Tech Transfer processes to incorporate lessons learned.
Write and maintain BOMs (Bill of Material), EBRs (Paper), gBMR (MES), and SOPs/WIs.
Candidate's Requirements: Minimum of 5 years work experience in the pharmaceutical or biotech industry.
Familiarity with Unit Operations for mAb manufacturing.
Basic project management knowledge.
Competent in issuing and transcribing information into documents required for manufacturing such as BOM, Batch Sheets, and DeltaV.
Competency in the use of automated/digital systems such as DeltaV, MES, eVal, and SAP COMET.
Working knowledge of GMP regulations.
Understanding of the general principles of New Product Introduction.
Preferably has managed a small project with a cross-functional group.
Apply: If you are interested in this position, you can send an updated CV in English to aguimard@ckqls.ch. Please quote job reference 117 115 in all correspondence.
It is essential that applicants hold entitlement to work in Switzerland.
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