Job ID: 12538

CSV/DI Engineer (gn)

Entourage ist ein Life-Science-Beratungsunternehmen mit Hauptsitz in München und weiteren Standorten in Basel, Mailand und Boston. Das Unternehmen verfügt über ein multidisziplinäres Team von über 180 branchenerfahrenen Beratern, die eng mit den Marktführern der Pharma- und Medizinprodukteindustrie zusammenarbeiten, um maßgeschneiderte Lösungen zu entwickeln. Durch seinen einzigartigen hybriden Ansatz, der Projekt- und Managementberatung kombiniert, ist Entourage in der Lage, seinen Kunden individuelle Lösungen im Life-Science-Sektor anzubieten.

Job Type.

Project Consulting

Your Tasks.

• Comply with cGMPs and DI requirements through applicable guidelines and procedures
• Bring previous experience of the Computerized System and Assets Lifecycle Management activities.
• Take part in OT Systems retrofit initiatives and projects
• OT systems introduction, upgrades, maintenance, and decommissioning
• Interface with Analyst, SME, SO and PO
• Develop content for Validation documents like Validation Plan, User Requirements, Design Specification, Test Protocols (IQ/OQ/PQ), Test Summary Reports following global standards and practices
• Maintain the availability of the OT Systems is in place to support key business objectives
• Provide training, documentation, and post-qualification support to users
• Maintain and schedule Periodic Reviews and maintain documentation updated
• Provide technical assessments on change controls, deviations, and investigations
• Collaboration with stakeholders (intra / inter Automation).
• Ensure that activities are performed on time for Audit trail and Periodic review
• Suggest improvements for Data & Digital innovation
• Support inspection readiness (on demand)
• Working closely with the Change Control owner to implement the system requirements
• Reviewing the user requirements together with the user
• Preparing cost estimations/calculations for the technical modifications
• Preparing the final technical documentation
• Review and approval of I/O/PQ execution documentation
• Be aware of the current state of the art in the field of Computerized System technologies and GAMP
• Challenge oriented, able to work autonomously
• Providing support in case of audits
• Serve as an internal advisor on pertinent processes and guidelines, assisting with correct comprehension and execution of CSV
• Get involved in CSV project teams or allocate tasks to qualified individuals
• Work alongside cross-functionally to develop, evaluate and approve CSV deliverables

Your Requirement Profile.

Critical / Key skills:

• Good Experience in pharma industry in GMP environment
• Experience with CSV/Pharma/Automation department and environment
• Preferably at least 3 years of experience in pharmaceutical/chemical/ food industry
• Experience in Computerized System Validation (CSV) activities
• Good experience with the Microsoft tools
• Good collaboration with supervisors and managers
• Understand the support request from end user teams or the priority of equipment default, and identify the need of escalation to the SO.
• Defines and understands user requirements for small modifications
• Identify priorities in collaboration with superior and user

Language & IT Skills:

• Fluent in Deutsch, English is very desired
• Good computer skills

• Knowledge and previously experience with network structure and architecture
• Knowledge and experience with SCADA systems (SuK, Groninger, Siemens, GEA), Historian (IP.21 Aspentech) and Inmation from Aspentech is a great plus

Pros.

Not specified.

Salary.

From: Not specified.
Until: Not specified.

Region. Category.

Süd