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IOT System Engineers, Life-science (Italy)

4 open positions

We are looking to expand our Consultancy & Integration Team in Italy. The ideal candidate has a background in either: IT Services, Process/Automation Engineering, IOT Integration Consulting or Quality Assurance / Validation support for Pharma/Biotech/Healthcare enterprises, good relational skills and Customer-oriented attitude.
This position is both creative and rigorous: by nature you need to think outside the box, by context you need to act in a highly regulated and controlled sector. We expect the candidate to be proactive and have a "get it done" spirit. To be successful, you will have solid problem solving skills.
Responsibilities:
Support Process Automation systems design, upgrade and integration projects (SCADA, DCS, PLC, etc...)
Address and resolve L2/L3 IT/OT incidents, problems and changes within the Customer IT/OT infrastructure
Monitor and manage large IT and/or OT networks
Write, update and review technical documentation (Functional Specification, Hardware Design Specification, Software Design specification, Risk/Impact assessment, Technical report, etc...)
Write and present project reports, presentations, technical reports, etc...
Survey and inspect Manufacturing areas and supervise installations and technical tasks
Keep up-to-date with both Customer and Internal standard operating procedures and best practices
Properly and thoroughly track activities and deviations
Contribute in assuring the Customer satisfaction and generating new business opportunities

Requirements:
Proven experience (1-2Y = Junior; 3-5Y = Mid; 6Y+ = Senior) in:
manufacturing automation systems design, upgrade and integration (SCADA, DCS, PLC, etc...)
manufacturing automation systems commissioning, supervising installations and technical tasks
IT/OT troubleshooting, workaround identification and application, solution definition
Proactive approach
Creative/innovation-keen approach
Dynamic and willing to learn and mature professionally
Teamwork-oriented
Language: Italian C1+ and English B2+
Right/Permit to live and work in Italy

Desired pharma-specific knowledge (optional):
Any OSI-PI related certification will be highly welcomed.
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 Activities.
SCADA Systems Planning, Integration, Commissioning, Maintaining, Upgrade.
Direct and Managed Control systems (PLC, Acquisition and User Experience levels) Planning - Blueprinting - Layout delivery.
Experience in Project Risk Management.
FAT/SAT protocols editing and execution.
Understanding/Knowledge of: ITIL and Service and Lifecycle Management, Business and Organisation Change Management, Computer System Validation.

Reports to:
Team Coordinator

Position details:
Location: Siena, Pisa
Travel: 20-60%
Type: full time, permanent
Business unit: Consulting & Integration
Level and salary: CCNL Terziario Confcommercio L3 - L1 + bonus, training and welfare plan (backgrounds and expertise will be assessed)

via Fiorentina, 153, Siena SI 53100, Italy
16/05/2022 03:43:56

Computerised System Validation Specialist

4 open positions

Dettagli della posizione:


Luogo: on site Imola (4 posizioni: 1 Senior, 3 Junior/Mid)
Contratto: tempo indeterminato, full time
Reports to: Project Leader
Livello e inquadramento: Commisurati al livello di competenza ed esperienza maturata + bonus, formazione e piano welfare.

Ricerchiamo per un nostro cliente di rilevanza internazionale, quattro specialisti in Computer System Validation con esperienza operativa nel settore Life Sciences.

Responsibilità:


Definizione e stesura Validation Plan, Report di Convalida, Test Plan, criteri di Accettazione, User Requirements.
Stesura e revisione di procedure standard (SOP) e Work Instructions.
Predisposizione dei documenti di specifiche tecniche (Design e Funzionali) e gestione delle revisioni e flussi di approvazione.
Scrittura ed esecuzione di protocolli di test IQ/OQ/PQ per sistemi computerizzati, processi, equipment e utilities.
Esecuzione di Impact Assessment tecnici.
Stesura e revisione di piani di calibrazione e di manutenzione.
Stesura e revisione di piani, test e procedure inerenti la qualifica di infrastrutture IT/OT.

Requisiti richiesti:


Elevato grado di conoscenza degli standard e delle norme del settore farmaceutico (ISPE GAMP e GxP, EUDRALEX, FDA CFR 21, etc).
Doti comunicative: Italiano e Inglese livello CEFR C1 o superiore (letto, scritto e parlato – il colloquio sarà svolto in entrambe le lingue).
Massima professionalità e serietà, capacità di mantenere un approccio distinto e formale nei confronti di clienti e colleghi/e.

Cosa offriamo?


Ampia possibilità di sviluppo di carriera.

Training formativi interni ed esterni all'azienda

Bonus di performance

Pacchetto welfare

Buoni pasto

Straordinari retribuiti secondo normativa

Team building


MAASI Enterprises vuole essere un’azienda inclusiva ed equa, in cui accogliere e valorizzare le differenze individuali.

Crediamo nelle pari opportunità per tutti, applichiamo condizioni di lavoro eque e retribuzioni rapportate alle responsabilità assegnate, alle competenze e al merito personali.

23/05/2023 10:32:55
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