Project Engineer - (GxP Environment)
Core
Ensuring GxP systems and processes adhere to regulatory requirements throughout the system lifecycle and managing the full project lifecycle of specific installations or equipment from specification to handover.
Role type
Project Engineer (GxP/Pharmaceutical)
Builds
Pharmaceutical installations, equipment, and compliant processes for clients in the life sciences industry.
Domain
Pharmaceutical manufacturing and regulatory compliance (GxP, GMP, EMA, FDA).
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP regulatory knowledge, project lifecycle management, specification and procurement, installation and validation, supplier technical follow-up, multidisciplinary team collaboration, planning and budget monitoring.
Preferred skills
Validation processes knowledge, sterile production experience, project coordination, contractor management.
Technologies
GAMP, ISO standards, validation tools.
Responsibilities
Monitor planning and budget, ensure safe and compliant execution, communicate with stakeholders, contribute to continuous improvement, provide support during audits and inspections.
Seniority
Mid-level, hands-on IC
