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, CAPEX engineering
Required skills
Qualification and validation expertise, GxP knowledge, Project management, Stakeholder management, Process optimization, Technical engineering background
Preferred skills
Knowledge of ISO 9001/13485/14644-1, ELT/TGA systems, Team leadership, Innovation identification
Technologies
GxP, ISO 9001, ISO 13485, ISO 14644-1, ELT, TGA
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; Consult internal business partners and develop standards like SOPs and test plans.
Seniority
Senior, hands-on IC
