Pharmaceutical Automation Engineer
Manage medium to large Capital Projects that include process control systems
Experiencie in pharmaceutical industry creating validation documentation
Detalles del cliente
International Pharmaceutical Company.
Descripción de la vacante
The main responsibilitiesa are to:
- Ensure that all manufacturing and related activities associated with automated control systems are performed in accordance with all relevant internal/external quality and safety standards.
- Manage medium to large Capital Projects that include process control system/equipment improvement, optimization, expansion and upgrade projects to meet site objectives.
- Manage new process control/automation projects from the concept to commissioning and validation documentation.
- Provide moderate to advance technical assistance to site operating groups through investigations, control system assessments, and design support.
- Assist in preparation and execution of the Validation Qualification protocols related to automated and control systems.
- Provide technical and non-technical feedback to validation personnel for the successful qualification of systems.
- Update and develop User Requirement Specifications, Functional Specifications, Design Specifications, Operation and Maintenance Manuals for the new and existing control systems.
- Perform validation activities in collaboration with Computer Systems Validation team.
Perfil del candidato
Electrical or Mechanical Engineering Degree. 6 years hands on experience with process controls equipment including PLCs, HMIs, SCADA systems, SQL relational database systems. 3 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment. Knowledge of Rockwell Automation ControlLogix and FactoryTalk technology would be advantageous. Experience and direct involvement in regulatory audits (FDA). Project Management experience is a plus. Capable of managing contractors and suppliers as well as internal teams. Advanced English level is required.
Oferta de empleo
- Benefits above law requirements
- Relocation package included