Kennziffer der Stelle
Operations — Engineering
3 bis 5 Jahre
AKKA & Modis are now Akkodis ranks as the European leader in engineering consulting and R&D services in the mobility sector. As an innovation accelerator for its clients, AKKA & Modis are now Akkodis supports leading industry players in the automotive, telco&media, industrial, aerospace, rail and life-sciences sectors throughout the life cycle of their products with cutting edge digital technologies (AI, ADAS, IoT, Big Data, robotics, embedded computing, machine learning, etc.).
With a view to strengthening our team, we are looking for a:
Product Development & Supply Consultant - Pharma
The resource will work to assure all logistical, quality & technical elements are in place for right first-time delivery of clinical material, providing technical and operational guidance to improve and to assure site readiness including Process Fit to Plant, scale-up and technology transfer.
The main activities include:
- Support to ensure drug product supplies and assuring timely delivery of clinical trial material
- Building and implementing KPI & Performance Matrixes for the EU CMO network
- Support to assure all logistical, quality & technical elements are in place for clinical manufacturing at the respective CMOs
- Focus on continuous improvement and cost saving initiatives at different CMOs and locations
- Bring in process engineering expertise to support development and technology transfer of robust and lean processes at the interface towards the development organizations
- Support the implementation of new enabling technologies and manufacturing platforms as well as supporting the establishment of new supply chain routes
The ideal candidate has a Degree in Science, Chemical Engineering, Bioengineering, Pharmaceutical Technology or Chemistry and at least 5-year working experience in Oral Solids and Liquid Process Technology. Geographical mobility is required at national and international level. Knowledge of the English language is required.
- Very good process management skills, Lean and Six Sigma qualifications
- Basic understanding of Clinical Manufacturing, Process Engineering & Scale-up, Pack & Label and Process Analytical Technology
- Knowledge of Cleaning and Process Validation, Technical Safety and Industrial Hygiene Standards, elementary knowledge of Facility, HVAC and Utility design & concepts
- Understand new product/process introduction
- Good understanding of ICH, cGMP, regulatory and other pertinent manufacturing and engineering guidelines and practices
Founded in 1984, AKKA & Modis are now Akkodis has a strong entrepreneurial culture and is pursuing fast-paced growth and international development in line with its strategic plan CLEAR 2022. The Group continues to recruit at a steady pace to support its strong business growth. As of 31 December 2021, the Group had 21.000 employees on an international level. Driven by its expertise in future mobility, digital and industry 4.0 technologies, the Group’s 2021 revenues amount to €1.553,4 million.
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