MSD Specialist Engineering - Solution Supply m/f/d 

Switzerland, Lucerne 

678534551

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.

will be a member of the Solution Supply Team within Drug Substance Support Operations at our Schachen Site. This position must be physically on site to support the team and its activities. The Specialist Engineering, Solution Supply has a variety of key responsibilities.

Responsibilities:

• Supporting in daily operations in the Solution Supply team: weighing and dispensing of raw material, preparation and dispensing of cell culture media and buffer used in the fed-batch and continuous manufacturing of mAb.

• Operation review of executed Batch Documentation

• Ensure full support to Good Manufacturing Practice (GMP) Drug Substance Manufacturing to seamless share resources to allow business continuity.

• Maintain GMP status of process equipment and areas by conducing routine monitoring, calibration, maintenance, certifications as needed.

• Perform investigations, root cause analysis and risk assessment to support deviations and change controls.

• Establish and maintain departmental procedures and practices to ensure efficient operation and continuous improvement, GMP documentation such as Standard Operating Procedure (SOPs), Batch Records, Buffer Memo, Qualification and Validation Protocols.

• Implement new technologies with software and instruments that can simplify and reduce effort around manufacturing and administrative processes.

• Assure the highest Quality, Compliance and Safety standards.

• Inspire Diversity and Inclusion – building effective working relationship within a cross-functional team across different cultures and backgrounds.

• Embody Safe by Choice and know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals.

• Developing future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch.

• Championing Ways of Working around Operational Excellence as well as EHS requirements via Gemba and tools like Enablon, with the aim of building and maintain a strong EHS culture.

• Collaborating across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally.

Your Profile:

• Bachelor’s degree in Biotechnology, Chemistry, Process Engineering, or another relevant discipline.

• Or an apprenticeship in a relevant field with over 5 years of industry experience.

• Professional GMP experiences in the pharmaceutical or biotech industry is a strong asset.

• Familiar with Single use systems in Bioprocess.

• Experience with quality management and compliance systems and in writing quality records.

• Competent in analyzing complex situations and show practical problem-solving capabilities.

• Oral and written communication skills in English and German.

• Ability to work independently and within a cross-functional team.

• Strong technical writing abilities.

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

• DeltaV and MES (Manufacturing Execution System) knowledge and experience is an advantage.

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.

Current Contingent Workers apply

Not ApplicableNot Indicated

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