CSV Engineer

Your task:
Ability to perform the following with limited guidance
Validation Planning
System Assessments GxP, ERES, Annex 11, Data Integrity
Functional Risk Assessments
Chair Design Review
Prepare RTMs
Prepare IQ, OQ & PQ Protocols & Reports
Validation Reports
CAPA Management
Dealing with Data Integrity issues including Centralized User Access, Audit Trails
Manage and work with equipment vendors and system integrators
Interact effectively with stakeholders – Engineering, Qualification, IT, QA, Users

Your profile:

Essential Attributes
10+ years Life Sciences experience in CSV in Life Sciences
Significant experience (+5 years) with CSV of Fill Finish equipment
Significant experience with Siemens S7, WinCC & Profinet
Significant experience with GAMP 5 SDLC
Significant with automation system migrations
Good knowledge of regulatory standard CFR Parts 210, 211 and Part 11
Fluent in English and able to understand communicate in German, excellent written English
Desirable Attributes
Experience with Interfacing with Werum PAS-X
Experience with interfacing with Aspentech IP 21 and/or OSI PI Historians
Experience with Virtualized Infrastructure, (VMs, VLANs)
OPC – UA including XML, PackML