MSD Specialist Engineering m/f/d 

Switzerland, Lucerne 

924639795

Job Description

Responsibilities:

• Executing daily operations in the manufacturing of mAb in Fed-Batch and Continuous
  Mode with initial focus in downstream processing.
• Ensure full support to Good Manufacturing Practice (GMP) Drug Substance Fed-Batch Manufacturing (Operations Tier 1 Team) 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 asStandard Operating Procedure (SOPs), Batch Records, Sampling Plans, 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.
• Support Weekend or On Call duty on select time frames to support manufacturing.
• 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.

Your Profile:

• Bachelor’s degree in Biology, Chemistry, Automation or Process Engineering, or another relevant discipline.
• Familiarity with Unit Operations for mAb manufacturing.
• Professional experiences with downstream processing such as Chromatography Steps and Ultra-/Diafiltration in a highly regulated industry is a strong asset.
• Proven understanding of Automation of manufacturing processes preferably on Delta V Platform
• Competent in analysing complex situations and show practical problem-solving capabilities.
• Oral and written communication skills in English (B1) would be must and German would be desirable.
• Ability to work independently and within a cross-functional team.

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

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.