Production Process Engineer (m/f)
Mithra
Liège, Belgium
5 dagen geleden

Description

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.

Mission

  • 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

    Profile

  • 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.

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