Direct message the job poster from CK QLS
Switzerland Recruitment Manager (Pharma & Med Device)
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 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 TT, 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 schedules 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 the development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
* Support the design and implementation of best practices in tech transfer.
* Assist in the development of future breakthrough business solutions, to reduce overall effort/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.
* Write and maintain BOMs (Bill of materials) and 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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Science and Manufacturing
Industries
Pharmaceutical Manufacturing
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