Duration: 2 years with the option for an extension
This position must be physically on-site to support the team and its activities.
Salary: 108'000 to 131'000 CHF gross per annum
As a member of the growing Biotech Process Engineering group, you will be responsible for the evaluation and implementation of novel equipment, innovative processes, and the implementation of next generation technologies, to keep the company at the forefront of innovation in development and clinical manufacturing of biologics.
Responsibilities
* Coach team and support coordination of efforts with colleagues across the local site and global company network in shaping and implementing next generation technologies and innovation for GMP Batch and Continuous Manufacturing in DS and DP.
* Contribute tiered meeting structure coordinating activities locally and with international (US, Ireland) groups for implementation of new processes and technologies for DS manufacturing.
* Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
* Act as an SME for the evaluation of innovative equipment for optimizing manufacturing processes, preparing user requirements and capital funding requests.
* Work to harmonize technologies in batch and continuous manufacturing
* Implement and qualify new technologies / software / instruments that can simplify and reduce effort around GMP manufacturing and administrative processes.
* Support the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs/WI’s.
* Provide quality assurance and GMP compliance support within global and interdisciplinary teams.
Qualifications
* A minimum of 5 years of work experience in the pharmaceutical or biotech industry.
* Experience as a Project Manager with cross-functional team members.
* Familiarity with Upstream and Downstream Unit Operations for biologics manufacturing.
* Effective oral / written communication skills in English (C1) is a must.
* Effective oral / written communication skills in German (B1) is highly preferred.
Preferred Experience and Skills
* Minimum of 3 years of experience with quality management and compliance systems, Working knowledge of quality auditing – preferred.
* Familiarity with Emerson DeltaV, SIPAT and the use of Automation in a manufacturing Process.
* Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification.
* Technical knowledge with Biologics drug substance operations and analytical testing or process development.
Apply
If you are interested in the role, you can send an updated CV in English at aguimard@ckqls.ch. It is essential that applicants hold entitlement to work in Switzerland.
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