Process Development & Improvement Manager

LausanneFixe2018-06-27Master / Université
Our Client, a growing medical device company, is looking for a Process Development & Improvement Manager to strenghten and manage the development team.

Process Development & Improvement Manager

Your Responsibilities

  • Manage the project development team, including hiring, performance management, training and professional development.
  • Manage the design and execution of process development (Preparation, Synthesis, Dialysis, degassing filling, sterilization) and appropriate Verification/validation activities accordingly applicable procedures and regulations.
  • Develop and/or review/approve documentation to support new and improved manufacturing processes per applicable procedures.
  • Maintain complete and thorough documentation in accordance with required US and international standards (e.g., ISO compliance, GLP/GMP/QSR requirements, etc.) for assigned projects.
  • Write and perform Validation plan strategy and process validations in collaboration with Validation team including methods for inspection.
  • Manage and control Risk process analysis and appropriate recommendations to mitigate the risk.
  • Manages Process Development team and provides technical support and guidance to help maintain project timelines while assuring compliance to all regulatory requirements.
  • Maintain regular communication channel on project activities (internally /externally) by project update /KPIs/ project minutes.
  • Direct contact with R&D and Manufacturing to understand new requirements for manufacturing processes.
  • Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on commercial products (PQR / annual review).
  • Work cross functionally with R&D, Manufacturing and Quality to optimize processes, address yield and quality issues and drive implementation of solutions in a production environment to meet production goals (CAPA/ MRB/ DCC meetings).

Your Profile

  • B.S./M.S./ PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnical Engineering
  • At least 6+ years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation.
  • Industrial experience working in a GMP compliant setting,
  • Knowledge on ISO 13485/ FDA 21CFR 820
  • Experience on statistic and SPC (Minitab)
  • Experience leading cross-functional teams in the development and scale up of manufacturing processes,
  • Experience with regulatory filings for Medical Devices and supporting regulatory inspections,
  • Positive behavior and good communication skills for effective liaison and teamwork,
  • Problem-solving skills, analytical skills and attention to detail,
  • Excellent organizational skills and the ability to work on several tasks or projects concurrently,
  • Presentation skills to present ideas and findings to colleagues and customers,
  • Ability to work well independently, with minimum supervision,
  • Drive, enthusiasm and self-motivation,
  • French –English speaking

Votre contact

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La référence de cette offre est JN -062018-50063