Beschreibung
Configuration Manager (m/w/d) - engineering/English/CMP/highly regulated/germanProject / Role:
For our client Roche Diagnostics in Rotkreuz we are looking for a highly motivated and qualified Configuration Manager (m/w/d)
Background:
The Department is looking for two Configuration Managers. The two position differ in terms of the Tasks & Responsibilities.
As part of the Diagnostics Governance & Services organization, the Configuration Management Team drives and to promotes an Integrated Configuration Management Process Excellence throughout Roche Diagnostics. We implement an End-to-End Configuration Management process in order to comply with applicable regulatory requirements, to enable managing the complexity and foster efficiency in the value chain by reducing rework and intervention resources, to know anytime the valid product design, build state and maintained configuration status of Roche DIA products and their components and to enable «One Roche» by common principles, standards and best practices in Configuration and Product Data Management throughout Roche Diagnostics.
Main Tasks
Prepare and update Configuration Management Plans (CMP) for products and projects
* Manage project and product Configuration Baselines and prepare and release: - Configuration Baseline Plan - Baseline Report - Configuration Note
* Manage product Baseline documentation verification and release
* Build up and manage the project and product CI structure in close collaboration with Engineering
* Manage project and product CI change process
* Establish and manage a simplified and harmonized CM process across the division to execute the CM vision - Identify, synchronize and monitor CM relevant initiatives - Implement BPM Process Improvement Proposals (PIPs) in CM process
* Establish divisional CM framework that is applied over the product lifecycle covering data, people, processes and tools
* Execute CM communication strategy to effectively engage with stakeholders - Proactively communicate simplified CM processes and standards throughout Roche DIA - Actively engage with all involved disciplines in the value chain
* Continuously analyze and improve CM data, people, processes and tools
Tasks & Responsibilities Configuration Management - Business Process Management (BPM):
* Establish CM Business Process Management (BPM) framework to consolidate and manage CM related activities across the division
* Build and strengthen BPM community
* Define and continuously improve BPM Process Improvement Proposal (PIP) process
* Organize and moderate BPM relevant meetings
* Establish and manage a simplified and harmonized CM process across the division to execute the CM vision
* Identify, synchronize and monitor CM relevant initiatives
* Implement BPM Process Improvement Proposals (PIPs) in CM process
* Establish divisional CM framework that is applied over the product lifecycle covering data, people, processes and tools
* Develop and execute CM communication strategy to effectively engage with stakeholders
* Proactively communicate simplified CM processes and standards throughout Roche DIA
* Actively engage with all involved disciplines in the value chain
* Continuously analyze and improve CM data, people, processes and tools
* Prepare and update Configuration Management Plans (CMP) for products and projects
* Build up and manage the project and product CI structure in close collaboration with Engineering
* Manage project and product CI change process
* Manage project and product Configuration Baselines and prepare and release:
- Configuration Baseline Plan
- Configuration Note
* Manage product Baseline documentation verification and release
MUST Have:
Academic degree in field of engineering with minimum 3 years of experience in Technician or Engineering area
At least 3 years of experience in the domain of Product Lifecycle Management and Configuration Management
At least 3 years of experience in medical device or other highly regulated industries
At least 3 years of experience in industrial Product Lifecycle Management processes
Experience with PLM tools required preferably covering the domains of configuration, document and change management
Experience with translating project and process needs and deliverables in systematically structured product data and user requirements
Excellent communication skills and expertise in stakeholder management, ability to identify customer needs and develop creative solutions
Good knowledge of the English language is required. German is a plus
Reference No.: 920092SGR
Role: Configuration Manager
Industry: Pharma
Location: RotkreuR
Workload: 100%
Start: 01.04.2021
Duration: 12++
Deadline: 28.02.2021
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.