Overview
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
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