In this role, you will be responsible for managing engineering projects related to mechanical upgrades in a regulated production setting. You will oversee design completion, coordinate with stakeholders, ensure GMP compliance, and lead qualification efforts to validate system performance.

Start Date: 22/09/2025

Duration: 12 Months

Place of Work: Visp

Key Responsibilities

  • Lead the completion of detailed design in accordance with project scope, GMP standards, and deliverables
  • Maintain the integrity of the design intent throughout all project phases
  • Review and approve technical documents, drawings, and specifications for quality and feasibility
  • Monitor project scope, timeline, budget, and risks, including handling change requests
  • Coordinate design activities among EPCM contractors, internal engineering teams, quality assurance, and operations
  • Support procurement processes, especially for long-lead equipment, aligning them with project plans
  • Ensure adherence to GMP regulations, company policies, and industry standards during all project stages
  • Collaborate with QA teams to ensure compliance with regulatory requirements
  • Maintain thorough project documentation such as risk assessments, design reviews, and qualification records
  • Manage project resources, including internal staff and external contractors, to meet deadlines
  • Develop and oversee project budgets, tracking expenses and addressing variances
  • Supervise performance qualification (PQ) activities, validating operational and regulatory compliance
  • Work closely with production teams during PQ to confirm operational improvements and system performance

Candidate Profile

  • Bachelor’s degree in Mechanical, Process, Chemical Engineering, or a related field; a Master’s degree is advantageous
  • At least 5–7 years of project management experience in a regulated manufacturing or biopharmaceutical environment
  • Proven success in managing GMP-compliant engineering projects from design to qualification
  • Experience collaborating with EPCM contractors and cross-functional teams, including operations and QA
  • Strong understanding of GMP regulations, change management protocols, and qualification processes
  • Excellent project management, budgeting, and scheduling skills
  • Outstanding communication and stakeholder engagement abilities
  • Proficiency with project management tools such as MS Project or Primavera
  • Problem-solving mindset with strong decision-making capabilities
  • Fluency in English, German skills are preferred

  • Certifications like PMP or Lean Six Sigma are a plus

     

     

Job ID 41181145