Prozess- und Projektspezialisten (m/w/d)
Core
Ensuring compliance with regulatory EHS and cGMP requirements while driving continuous improvement in pharmaceutical manufacturing operations.
Role type
Senior process and project specialist (manufacturing)
Builds
Pharmaceutical production systems and immunotherapy products
Domain
Biotechnology / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Process technology, GMP compliance, Lean Six Sigma, Project management, Change management, Root cause analysis, Data visualization, Stakeholder engagement
Preferred skills
Experience in pharmaceutical operations, Bio-process technology knowledge
Technologies
MEDS, Value Stream Mapping, Hoshin Process
Responsibilities
Ensure adherence to regulatory EHS and cGMP standards; Coach teams on production systems and change management; Lead LEAN projects for process efficiency; Coordinate cross-functional problem-solving and risk assessments; Create and approve GMP documents and support equipment/process validation; Visualize data for decision-making and track KPIs.
Seniority
Senior, hands-on IC