Packaging Process and Project Engineer

vor 1 Monat

Aubonne, Schweiz Merck KGaA, Darmstadt, Germany Vollzeit

As part of the Supply Operation from Aubonne site, you will join the PSAT (Packaging Science & Technology) team in charge of project management to support the Packaging activities.

Your Role:
  1. Project Management:

    You will manage packaging project activities related to the launch of new products on site in time. You will be the representative person regarding these activities for the Supply Operations. You will be in charge of projects related to lifecycle management of our Packaging portfolio to ensure their supply continuity. You will manage technical transfer of technology between sites and with contract manufacturing organizations. Based on your knowledge, you guarantee an efficient project management methodology to deploy your projects on time. You will be the representative person on site within the development of new products to prepare the launch of new products.

  2. Process Management:

    As a PSAT member, you will be the owner of the process validation strategy at the packaging level. You will be in charge of the redaction of URS, Validation plan, and all the documentation associated with a process validation. You will execute Process validation, material qualification, packaging performance validation, and shipping validation following SOP on site. You will manage and collaborate for the implementation of risk analysis (process, product, technical). You will be the support for technical qualification on line led by other departments.

  3. Compliance, Quality and Documentation:

    You will ensure that validation documentation is up to date in our document management system. You ensure project traceability in our quality system and our Project management tool. You are in charge of the opening of project deviation and leading investigations related to your project. You will be the Subject Matter Expert for process validation and projects related to the product launch of new products.

Your Profile:
  • Master in Engineering or in a Pharmaceutical field with a minimum of 5 years of relevant project management experience.
  • Strongly familiar with cGMPs and regulatory guidelines.
  • Technical knowledge of packaging and assembling processes.
  • Ability to apply strong fundamental scientific and engineering skills to evaluate, develop, and implement innovative solutions to technical challenges.
  • Strong leadership and competitive mindset to interact with cross-functional teams.
  • Fluent in French and English.
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