Mithra is looking for an Process & Production Expert. to join its Process and Production Support department to work at Mithra CDMO, its R&D and Manufacturing platform located in Flémalle.
Support production department during projects and continuous improvement initiatives
Support production department during routine activities
Support Mithra CDMO during audits and inspections
Develop specific expertise to support other PPS team members
Build and consolidate bridges with the other support functions such as R&D, QC, Validation, Engineering
Duties and responsibilities
Lead or Participate to New Process Introduction projets
Lead new product introduction projects / Product transfert
Work closely in collaboration with production team from project initiation until launch for commercial activity. According to project roadmap, manage, drive or support activities related to implementation of changes and improvements
Apply project management and lean manufacturing basic principles to efficiently support and influence production projects
Work in close collaboration with other support functions such as Validation, Cleaning, EM, Engineering, QC, automation, IT, EHS, QA, CMC,
Interract with suppliers for new equipements sélection, spare parts, new forma, trouble shooting,
Develop and / or support writing of new protocols, risk assesemnts, reports, required during projects phases
Support issue investigation, propose pragmatic solutions, drive or support implementation
Ensure compliance with GMP and safety procedures as well as company SOPs and general policies to ensure the required quality standards
Develop and / or support writing of new operating SOP / WKI / BR / required for the launch of a new activity, product, equipement
Train or support training of operationnal personnel. Ensure knowledge transfer
Ensure support and / or provide training to newcomers.
Contunuously transfer knowledge to the production personnel to develop capabilities and authonomy
Ensure support for SOP / WKI / BR updates and improvements
Support or lead troubleshooting, deviation investigation, remediation and / or CAPA plan definition and implementation
Collaborate to or drive PQR activities
Introduce KPI’s in order to measure performance of production
Act as change agent : analyse production trending, identify areas where profit improvements can be deployed, cost saving, efficiency improvments, quality, right-first-time, simplification.
Propose continuous improvement
Pharmacist (Galenic knowledge would be a must), process or chemical engineer, Generalist engineer
Significative experience in pharmaceutical industry or food industry
Experience in product transfer is an asset
Consumer oriented, positive attitude, open minded
Ability to work in project mode or matrix organization, with multiple interactions
What we offer
Varied and motivating responsibilities within a fast growing company.
An attractive salary package in line with your experience.