MSD Senior Specialist Engineering - Large Molecule 

Ireland 

942365746

Job Description

Large Molecule Technical Operations Site Support (LMTO SS)

Given the diverse roles that will played by the successful candidate, the role requires high levels of flexibility, adaptability, innovation, enthusiasm, and a broad technical knowledge base across multiple different areas. The position will be located at one of our company's sites and will involve primarily working remotely from a site but with flexibility to work virtually.You may be required to be available to travel to sites within Europe and/or North America, at approximately 10-25%.

Whatyou will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Provision of direct support to drug substance and/or drug product manufacturing sites
• Strategic project leadership for multi-site technical or continuous improvement initiatives
• Supporting and/or leading technology transfer activities at our manufacturing nodes
• Facilitation and leadership of quality risk assessments and after-action reviews
• Leading and/or supporting complex and/or multi-site investigations
• Ensuring best practices are documented, communicated and implemented across manufacturing nodes
• Leading and/or supporting supplier related technical issues
• Support of inspections at manufacturing nodes
• Authoring, reviewing regulatory documents and supporting regulatory responses
• Authoring, reviewing and approving technical study protocols, memos and reports
• Support person-in plant activities for technology transfer and lifecycle management changes
• Actively participates in a culture of continuous improvements and process optimization
• Providing technical direction in the interpretations of trends observed in process monitoring and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.

In order to excel in this role,have:

• A BSc, MSc or PhD in a science or engineering field ideally specializing in the life sciences areas
• Have a deep understanding of the science and technology behind large molecule manufacturing processes
• Possess a deep understanding of manufacturing/operational GMP (Good Manufacturing Practice) including change control, quality risk management, quality notifications and conducting detailed and complex investigations
• Demonstrated experience and knowledge in cell culture with emphasis on mammalian cell culture
• Demonstrated experience with data analytics, statistical process control and multivariate analysis
• Demonstrated experience in regulatory filing authoring, regulatory inspection support and/or regulatory responses and interactions
• Demonstrated experience in large-scale validation and process characterization
• Strong problem-solving skills and a hands-on approach to problem solving.
• Demonstrated experience in leading and/or managing projects
• Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it
• Ability to work independently and on own initiative with minimal direction from management
• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required
• Enthusiasm and initiative-taking ability needed for continuous learning and its applications
• Working understanding of analytical methods to characterize biopharmaceutical processes and/or US/EU regulatory requirements

So, if you are ready to:

Current Contingent Workers apply

Not Indicated

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