Process Engineer II

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 would be a 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 and activities can be tailored to successful candidate availability and career plan would primarily entail, but are not limited to:

• Support of developing tech transfer program.
• Collaborate with the team and stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, 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.
• Manages 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.
• Supports design and implementation of best practices in tech transfer.
• Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, optimizing these to make way for rapid product launch, to progress the team forward to “one-click” tech transfer.
• Provide feedback and propose opportunities for optimization to current Tech Transfer processes to incorporate lessons learned.
• Writing, maintaining of BOM's (Bill of material) and EBR’s (Paper), gBMR (MES) and SOPs/WI’s.

Candidate's Requirements:

• Minimum of 5 years work experience in the pharmaceutical or biotech industry.
• Familiarity with Unit Operations for mAb manufacturing.
• Project management basic 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, SAP COMET.
• Working knowledge of GMP regulations.
• Understanding of the general principles of New Product Introduction.
• Preferrably 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 Engish to aguimard@ckqls.ch. Please quote job reference 117 115 in all correspondence.

It is essential that applicants hold entitlement to work in Switzerland.