For one of our clients, a global pharmaceutical company, we are looking for a Process Engineer - Tech Transfer Specialist.
General Information:
- Start date: ASAP
- End date: 1 year with a possibility of extension
- Workplace: Schachen, Lucerne
- Workload: 100%
- Working Hours: Standard
- Home Office: hybrid role
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About the job:
In this role, you will be a member of the Manufacturing Operations team, reporting to the Technology Transfer Lead. You will be supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy.
As a Process Engineer - Technology Transfer Specialist you will be a Change Champion within the organization and site, to bring about new products, digitization, and ways of working.
Tasks & responsibilities:
Responsibilities and activities can be tailored to successful candidate availability and career plan and 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.
- Supports 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.
- Demonstrate excellent troubleshooting and problem-solving skills, as well as the ability to collaborate and work effectively within global and interdisciplinary teams.
- Demonstrate a desire for continuous learning, improvement, and development, while approaching problems from new perspectives.
- Support to aggregate process related knowledge and centralize for knowledge management.
- Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
- Ensure the highest Quality, Compliance and Safety standards.
Requirements:
- A degree qualification in a relevant field (Science/Technical)
- Minimum of 5 years of work experience in the pharmaceutical or biotech industry
- Familiarity with Unit Operations for mAb manufacturing
- Fluent in English
- 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
- Has managed a small project with a cross-functional group
- Working knowledge of cGMP regulations
- Understanding of the general principles of New Product Introduction (Tech Transfer)
Nice to haves:
- Oral / written communication skills in German.
- Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
- Competent in analyzing complex situations and showing practical problem-solving capabilities.
- Familiarity with risk assessment processes.
- Competent in analyzing complex situations and showing practical problem-solving capabilities.
- Familiarity with the use of Automation systems in a manufacturing Process.
- Ability to work effectively as part of a team and independently.
Sounds interesting? Apply now – we’re looking forward to receiving your applications!
