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Process Engineer

vor 1 Monat

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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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