Process Automation Engineers, Pharmaceutical
We are seeking for Automation and Process Engineers with Mid and Senior expertise in the Pharmaceutical and Biotechnology markets to grow our CompetenceDelivery™ Excellence Consultancy Team.
The CompetenceDelivery™ Consultant reports to the Executive Account Manager assigned to the Customer the service is related to, and works as on-site Consultant with our Enterprise Customers.
It is responsible for:
- Writing and Revision of technical documentation (URS, Functional Specification, Hardware Design Specification, Software Design specification, etc...)
- Process Automation systems design and upgrade (SCADA, DCS, PLC, etc...)
- Coordination and preparation of support documents and processes in reference to maintenance and upgrade projects (DUVRI, HSE documentation, access control requests, etc)
- Preparation of reports, presentations, technical reports, etc...
- Surveying and inspecting Manufacturing areas
- Supervising installations and technical tasks
- Coordinating and executing Enterprise Pharma Customers transformation/integration/evolution/M&A projects
- Coordinating and executing Enterprise Pharma Customers Quality Assurance and Control related projects
- Keeping up-to-date with both Customer and Internal standard operating procedures and best practices
- Keeping up-to-date the project documentation
- Tracking activities and deviations
- Assuring the Customer satisfaction
- Customer PMO / local Executive
- assigned Executive Account Manager
- Siena (Primary), Verona, Torino, Venezia (Secondary)
- Type: full time, permanent
- Selection completed by: Sep. 15th 2018
- Last person hired by: Oct. 15th 2018
- Experienced Process Automation Engineer in Pharmaceutical environment (3+ yrs).
- Experience in Projects Risk Management.
- Knowledge and Experience of Documentation Lifecycle management.
- Deep knowledge and understanding of major Pharma regulations (FDA 21 CFR parts 11, 210 & 211, part 80).
- Deep knowledge and understanding of Good Manufacturing Procedures (EUDRALEX GMP).
- Experience in management and follow-up of Commissioning and Pre-Commissioning Activites.
- SCADA Systems Planning, Integration, Commissioning, Mantaining, Upgrade.
- Direct and Managed Control systems (PLC, Acquisition and User Experience levels) Planning - Blueprinting - Layout delivery.
- FAT/SAT protocols editing and execution.
- Microsoft Office (including Project) advanced user.
- Proactive and dynamic approach to issues
- Optimistic approach to problems
- Able to be a member, coordinate or manage a Team of People
- Patience and professionalism in speaking to Customers and Partners
- Able to work on stressful environments
Required Language levels
- Italian, C1+
- English, B2+
Nice-to-have Skills and Expertise
- ITIL v3, Senior
- IT skills and knowledge
- Creative mindset
- French, B1+