PROCESS ENGINEER

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.
.
PAT, spray drying, digitalization, …) Manage Product Transfer / Product Introduction Closely working with Technical Owner and (or) Technical Launch Integrator (TLI) to accomplish site-to-site technical transfers and be responsible for EM site activities of registration and validation campaigns Perform 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).
Develop good understanding of status of 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.
Maintain and follow up action log with observations / suggestions to 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 Contribute to Standardization initiatives for MSAT Build technology expertise (e.
., 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, from a process viewpoint.
Be 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.
Qualifications COMPETENCY (knowledge, skills, abilities and experience required).
5-10 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.
PHYSICAL REQUIREMENTS/WORKING CONDITIONS.
Works in an international environment across different time zones Frequent travel required Travel.
~ 25% - project dependent