Senior Validation Engineer

vor 2 Wochen

Schaffhausen, Schaffhausen, Schweiz Johnson & Johnson Vollzeit

About the Role:

We are seeking a highly skilled Senior Validation Engineer to join our team at Johnson & Johnson Innovative Medicine. As a key member of our MSAT LM Cross Platform Engineering group, you will play a strategic and tactical role in Global MSAT, partnering with R&D, Make functions, New Product Introduction, the Quality Organization, and Value Chain Management teams to develop and implement robust manufacturing processes.

Key Responsibilities:

  • Single Point of Contact (SPOC) for MSAT needs for LM and parenteral products regarding Life Cycle Process Validation (LCPV) and Continued Process Verification (CPV).
  • Manage communities of practices and know-how around LCPV and CPV within the firm, maintain current internal guidance on LCPV and CPV.
  • Proactively promote quality and compliance in the areas of LCPV and CPV and coach others to do the same.
  • Oversee technical support to regulatory filings, regulatory inspections, and health authority questions.
  • Collaboration in technology transfer projects supporting implementation of new processes in manufacturing operations regarding criticality analysis, control strategy, validation, and CPV by means of coordinating technical writer work.

Qualifications:

  • Expertise on pharmaceutical manufacturing processes and products.
  • Knowledge of Quality & Compliance / regulatory requirements (GMP) especially for life cycle process validation and quality risk management.
  • Process excellence (6sigma) and statistical understanding.
  • Project management (FPX), organizing, planning, and coordination skills.
  • Personal and interpersonal skills.
  • Ability to work in a cross-functional / cross-regional project team.
  • Ability to manage complexity and change.
  • Ability to interact at different levels of the organization.
  • Ability to work under pressure, handle conflicting interests, and take decisions.
  • Customer and business focus, team player.
  • Personal attitude and mindset.

Education:

Undergraduate degree in Science, Engineering, Business, or Supply chain subject areas required. Post-graduate degree preferred.

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