senior process engineer (biotech process engineering).

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 at the forefront of innovation in development and clinical manufacturing of biologics.

Tasks & responsibilities:

• Coach team and support coordination of efforts with colleagues across the local site and global 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.

Requirements:

• 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.
• Business Fluent in English (C1) and German (B1).

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 your own initiative in a constructive manner.

Sounds interesting? Apply now – we’re looking forward to receiving your applications!