Principle Engineer, MSAT SMDS EM

Conteúdo do emprego

Position Summary

This position involves taking technical ownership at external manufacturing sites, working with internal and external partners to implement life cycle management (LCM) and introduce new products (NPI) in line with product roadmap and supply chain strategy.

By Closely Working With Key Business Partners From Partnership & External Supply (PES), Quality, Procurement, Value Chain Management (VCM), R&D, EHS And MSAT Functional Teams, This Position Will Actively Participate And Contribute With The Dedicated Focus On

• New Product Introduction (NPI) / Life Cycle Management (LCM)
• Process Validation/Verification
• Process improvements
• Standards and new technology deployment (e.g. PAT, spray drying, digitalization, ...)
  
  

Principal Responsibilities

Manage Product Transfer / Product Introduction

• Closely working with Technical Owner and (or) Technical Launch Integrator (TLI) to lead/support site-to-site technical transfers and be responsible for EM site activities of registration and validation campaigns
• Lead the Technical Assessment and Process Fit to Plant exercises
• Manage product life cycle / LCM portfolio
• Be the primary contact for technical issues related to assigned CMO sites and be a key member of Virtual Management Team (VMT).
• Cultivate comprehensive of understanding of status for ongoing and future planned technical activities at EM sites.
• Bring technical insights to deviation investigation & technical issue escalation within VMT to assure timely resolution.
• Coach and support EMs to handle troubleshooting / investigation with profound process understanding.
• Drive manufacturing excellence by improving operation/process efficiency, process robustness and intensity.
• Coach and support suppliers performing process data analysis, process modelling (with Global SME support) and statistical process control in order to characterize process capability and to increase process understanding.
• Evaluate supplier-initiated change initiatives from technical perspective.
• Owner of technical section in Account Plan for assigned EMs and engage other MSAT roles at the site to keep corresponding part updated.
• Monitor and communicate supplier performance against established metrics. Develop and follow up improvement plans for supplier performance in collaboration with VMT.
• Standardization & Innovation
• Lead and contribute to Standardization initiatives for MSAT
• Build technology expertise (e.g., Spray Drying, PAT, CM and high-containment techniques, etc.) on current technologies and support evaluation and introduction of new process technologies by participating/leading the joint technology teams.
• Gain expertise in current equipment capabilities and new process technologies linked with spray drying or new products. Be a key contributor to drive technological vision.
• Build comprehensive and profound knowledge and integrate this knowledge in the organization. Provides comprehensive process advice. Facilitates resolution of sophisticated operational problems.
• Build a strong network with departments like manufacturing, quality, technical engineering, R&D to be able to develop and complete these projects and deliver process requirements.KNOWLEDGE SKILL AND ABILITY REQUIREMENTS:
  
  

COMPETENCY (knowledge, Skills, Abilities And Experience Required)

• 10-15 years’ experience in a cGMP API manufacturing environment.
• Experience in developing/ introducing/scaling-up chemical processes and managing/overseeing commercial production.
• Good project management skills in process know-how transfers.
• Statistical skills required to perform process data analysis/process modelling/SPC.
• Deep understanding of typical unit operations and related process equipment
• Technical knowledge of some of the following is highly valued: spray dryer/dryer, process analytical technologies (PAT), Continuous Manufacturing (CM), high-containment techniques, data analytical tools/digitalization
• Trouble-shooting experience/ Affinity with related methodologies.
• Must have cross-cultural mindset
• Must be highly skilled at collaboration and comfortable working in a matrix organization
  
  

Degree

Minimum requirements: University Degree. Desire MSc or PhD in Chemistry / Chemical Engineering / Biotechnology / Pharmaceutical Science, etc.

Languages

Fluent in written and spoken English.

Specific Systems

SUMMIT

Deviation/Event/Investigation/CAPA Management System (TrackWise or equivalent)

Document Management Systems (Truvault, SharePoint, ...)

Concur

Workday

Physical Requirements/Working Conditions

Works in an international environment across different time zones

Frequent travel required

Travel: ~ 25% - project dependent