Project Engineer (m/w/d) Qualifizierung
Core
Lead and coordinate qualification and validation of computerized systems, machines, and plants in complex local CAPEX projects (Green- and Brownfield) from planning to handover.
Role type
Senior Project Engineer (Qualification & Validation)
Builds
Computerized systems, machines, and plants for pharmaceutical manufacturing and diagnostics
Domain
Pharmaceutical industry, GxP compliance, CAPEX engineering
Required skills
Qualification and validation expertise, GxP knowledge, Project management, Stakeholder management, Process optimization, Technical documentation, Team leadership, Problem-solving, Regulatory knowledge, English communication
Preferred skills
Experience with ELT/TGA systems, Knowledge of ISO 13485/14644-1, Ability to manage external service providers
Technologies
GxP frameworks, ISO 9001, ISO 13485, ISO 14644-1, ELT/TGA systems
Responsibilities
Ensure proper qualification, validation, and documentation of projects; Lead project teams and manage external service providers; Plan, steer, and monitor CAPEX sub-projects; Identify and implement innovative technologies; Engage in the Engineering Community and drive knowledge exchange; Advise internal business partners and develop qualification concepts and SOPs
Seniority
Senior, hands-on IC
