Process Engineer III

CK QLS are looking for an experienced biotech process engineer, to join a global biopharmaceutical company, in canton of Lucerne, for a duration of 2 years.

Duration:

2 years contract, fully onsite role.

This is an Engineer Position, within the Process Engineering team, at the Company Facility in the greater Lucerne area.

This position must be physically on site to support the team and its activities.

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.

Senior Specialist Process Engineering:

• 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 Drug Substance and Drug Product.
• Contribute tiered meeting structure coordinating activities locally and with international (US, Ireland) groups for implementation of new processes and technologies for Drug Substance manufacturing.
• A Change Champion within the organization and site, to bring about new technologies, digitization, and ways of working.
• 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, for easy flexibility in switching between the two paradigms.
• 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.
• Aggregate process related knowledge and centralize for knowledge management.

To be successful in this role, you will have the following:

• 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.
• Competent in analyzing complex situations and showing practical problem-solving capabilities.
• 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.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.

Apply:

If you are interested in the role, you can send an updated CV in English to aguimard@ckqls.ch.

It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 136 826 in all correspondence.