MES Engineer - PasX

Cognizant Life Sciences Manufacturing; Napoli; In loco; EUR 70.000 - 95.000; Tempo pieno

Descrizione del lavoro

Cognizant Life Sciences Manufacturing in Napoli, Italy is seeking an experienced MES specialist to lead end-to-end MES implementations, especially PASX design and validation. The role focuses on delivering compliant, scalable MES solutions aligned with GMP and Pharma/Biotech requirements.

The ideal candidate will drive system governance, data modeling, and eBR authoring across multi-site deployments, ensuring timely delivery and adherence to regulatory standards.

Competenze

• Multiple years of MES experience, specifically with MBR design in PasX.
• Hands-on experience with deployment of MES.
• Strong knowledge of ISA-88/ISA-95 standards, GMP regulations, and MES best practices.

Mansioni

• Lead and manage MES implementation phases including design, configuration, validation, deployment, and support.
• Translate business requirements into PASX system design and functional specifications.
• Provide governance over PASX object modeling, system integration and recipe life cycle management.
• Conduct project planning, risk management, and progress tracking aligned with GxP and project goals.
• Serve as technical advisor for CRs, GMP readiness, and MES operational strategies.
• Create data and equipment model for implementation of MES functionalities.
• Author and configure MES eBRs
• Development and update of SOPs.
• Test, validate and demonstrate eBRs. Post go-live support

Conoscenze

MES experience

Leadership

GxP compliance

ISA-88/ISA-95

Biotech/Pharma MES deployments

Formazione

Bachelor or Master in Engineering/CS or related

Strumenti

PASX

Descrizione del lavoro

Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimized to improve operational efficiencies, whilst maintaining compliance.

Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services.

Operating across 5 continents and with over 300.000 skilled employees, Cognizant partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market. We are your single end to end partner for consultancy, design implementation, optimization and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.

We're looking for dedicated, innovative and driven talent to join our expanding team.

Responsibilities:

• Lead and manage MES implementation phases including design, configuration, validation, deployment, and support.
• Translate business requirements into PASX system design and functional specifications.
• Provide governance over PASX object modeling, system integration and recipe life cycle management.
• Conduct project planning, risk management, and progress tracking aligned with GxP and project goals.
• Serve as technical advisor for CRs, GMP readiness, and MES operational strategies.
• Create data and equipment model for implementation of MES functionalities.
• Author and configure MES eBRs
• Development and update of SOPs.
• Test, validate and demonstrate eBRs. Post go-live support

Requirements:

• Multiple years of MES experience, specifically with MBR design in PasX.
• Must have hands-on experience with deployment of MES.
• Strong knowledge of ISA-88/ISA-95 standards, GMP regulations, and MES best practices.
• Strong knowledge of Master data management and configuration
• Excellent leadership, communication, and client engagement skills
• Proven leadership in large-scale Pharma/Biotech MES deployments.
• Familiarity with Bioconjugate or Biologics processes
• Background in multi-site/global MES governance models
• Bachelor or Master in Engineering, Computer Science, or other related discipline.
• MES/SCV/GAMP certification is preferred
• PMP or Agile certification a plus.
• Fluent Italian proficiency

At Cognizant, we engineer modern businesses to improve everyday life because we are dedicated to making a lasting impact. Cognizant (Nasdaq: CTSH) engineer's modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we are improving everyday life. See how at www.cognizant.com or @cognizant.