MSD Biotech Process Engineering Specialist Technology m/f/d 

Switzerland, Lucerne 

245763722

Job Description

The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. A multi-product strategy for Technology Transfer and Facility Fit will enable the facility to adapt in a flexible and agile way for rapid product launch.

As a member of the growing Biotech Process Engineering team, you will play a key role in the evaluation and implementation of novel equipment, innovative processes, and the implementation of next generation technologies to keep our company at the forefront of innovation in development and clinical manufacturing of biologics.

Responsibilities:

• Assisting in creating and maintaining project plans from evaluation and sourcing through qualification implementation and Good Manufacturing Practices (GMP) release of equipment and technologies.

• Supporting the introduction of novel and innovative solutions for biologics manufacturing within the facility.

• Handling capital requests and procurement tasks under supervision.

• Build an excellent relationship with Technology Lifecycle Excellence, Process Automation and Drug Substance Manufacturing Operations teams.

• Providing guidance, motivation, and support to project team members across departments.

• Collaborating with production managers and other stakeholders to understand production requirements, capacity constraints, and priorities.

• A Change Champion in the organization and site, driving new technologies, digitalization and finding opportunities for innovative work methods.

• Serving as a subject matter expert (SME) for newly implemented technologies and guiding their integration into routine production through knowledge transfer.

• Supporting the development of GMP Documentation such as Risk Assessments, Qualification Documents and authoring standard operating procedures and work instructions.

• Collaborating with Facility Management and internal team members to ensure GMP compliance through routine monitoring, calibration, maintenance, and certifications of responsible equipment devices.

• Authoring protocols and conducting design of experiments to demonstrate the comparability of new technologies with legacy systems.

• Demonstrate excellent troubleshooting and problem-solving skills, as well as the ability to collaborate and work effectively within global and interdisciplinary teams.

• Demonstrate a desire for continuous learning, improvement, and development, while approaching problems from new perspectives.

Your Profile:

• A degree qualification in a relevant field (Science/Technical). An Advanced Degree (BSc or MSc) is desirable.

• A minimum of 5 years of work experience in the pharmaceutical or biotech industry.

• Or an apprenticeship in a relevant field with over 7 years of industry experience.

• Technical knowledge in biologics drug substance upstream operations, downstream operations, analytical testing or process development.

• Project management basic knowledge.

• Experience working in a GMP and or a regulated environment.

• Experience in quality change management systems.

• Strong technical writing abilities.

• Good understanding of general principles of equipment qualification.

• Understanding the design and functionality of automated systems like Emerson DeltaV, as well as the application of automation within manufacturing processes.

• Competent in analyzing complex situations and showing practical problem-solving capabilities, with a desire to continuously learn, improve and develop.

• Ability to work effectively as part of a team and independently.

• Proficient verbal and written communication skills in English. German would be desirable.

Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.

What we look for …

Current Contingent Workers apply

Not ApplicableNot Indicated

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