Job Detail

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Job Titel

Global Serialization Shop-floor Application Owner

Job Beschreibung

Role:

The Shop-floor Serialization Application Owner is the pivotal role that owns the global shop floor Serialization applications. He is designing and coordinating the services supplied to support the shop-floor processes for the manufacturing sites with Global IT Infrastructure, Local Operational Technology (OT) team, and the suppliers of the solutions. He is responsible that the services delivered are operating, performing efficiently and in compliance with the desired level of service agreed with each customer. Responsible to establish a strategy with the Process Owner and local stakeholders to improve existing services.

Main Responsibilities:

• Design shop-floor Serialization solutions to fulfil complex requirements of a heavily regulated Pharma Industry with as less customization as possible. Design global and cross functional standard processes linked with the use of the solution and find solution to enable testing without the need of production equipment


• Ensuring the implementation is prepared and managed properly with the definition of a methodology to enable a fast-paced implementation or fast paced upgrade.


• Maintain a clear roadmap aligned with the business objectives. Pro-actively identify process improvement and process redesign opportunities. Lead and facilitate prioritization and decisions on improvements and harmonization across sites, coming from the all stakeholders from the business areas


• Ensure deep and pro-active understanding of the supplier solution versus regulatory requirement. Follow-up and influence the development of the solution provided by the vendor to be able to answer quickly to business needs, sharing with the Serialization Process Owner and adapt the solution accordingly


• Establish and manage the relationship with Global IT and the supplier to ensure a service agreement is in place and the KPI are met


• Build a network of subject matter expert across manufacturing sites, ensure they are identified, properly trained and following common processes with supporting documentation available. As the senior advisor on problem solving approach, accountable that problem resolution expertise and best practices are developed, documented and shared within the network


• All activities are conducted in compliance with relevant external and internal regulations and guidelines (quality, safety, integrity, security and change control). Ensure validation roles and responsibilities are clearly defined and well understood by each site to avoid confusion during audit


• Establish a release management process aligning regulations requirement, user requirements and new software versions to always stay in the support window while minimizing supply disruption.

Required Experience & Competences:

• University degree (Master’s or equivalent) in Computer science


• 10 years’ related management experience in technology related to Manufacturing.


• 10 years’ experience in process Industry and Operational Technology


• 10 years’ experience architecting solutions


• Experience of GXP regulated work within the Pharmaceutical Industry (GXP/GMP, FDA 21 CFR part 11)


• English – Fluent in speaking and writing


• Proven ability to facilitate, manage and lead people in either Project or Line of Business


• Excellent communication skills talking to organization at all levels


• Strong analytical & problem-solving skills


• Proven strong project management experience in the field of Automation/OT//IT systems


• High commitment and result oriented


• Good communication, good leadership, organized & proactive approach


• Innovative mindset


• Customer oriented

Ort

Switzerland HQ - St-Prex </div>

Job Titel

Global Serialization Shop-floor Application Owner

Job Beschreibung

Role:

The Shop-floor Serialization Application Owner is the pivotal role that owns the global shop floor Serialization applications. He is designing and coordinating the services supplied to support the shop-floor processes for the manufacturing sites with Global IT Infrastructure, Local Operational Technology (OT) team, and the suppliers of the solutions. He is responsible that the services delivered are operating, performing efficiently and in compliance with the desired level of service agreed with each customer. Responsible to establish a strategy with the Process Owner and local stakeholders to improve existing services.

Main Responsibilities:

• Design shop-floor Serialization solutions to fulfil complex requirements of a heavily regulated Pharma Industry with as less customization as possible. Design global and cross functional standard processes linked with the use of the solution and find solution to enable testing without the need of production equipment


• Ensuring the implementation is prepared and managed properly with the definition of a methodology to enable a fast-paced implementation or fast paced upgrade.


• Maintain a clear roadmap aligned with the business objectives. Pro-actively identify process improvement and process redesign opportunities. Lead and facilitate prioritization and decisions on improvements and harmonization across sites, coming from the all stakeholders from the business areas


• Ensure deep and pro-active understanding of the supplier solution versus regulatory requirement. Follow-up and influence the development of the solution provided by the vendor to be able to answer quickly to business needs, sharing with the Serialization Process Owner and adapt the solution accordingly


• Establish and manage the relationship with Global IT and the supplier to ensure a service agreement is in place and the KPI are met


• Build a network of subject matter expert across manufacturing sites, ensure they are identified, properly trained and following common processes with supporting documentation available. As the senior advisor on problem solving approach, accountable that problem resolution expertise and best practices are developed, documented and shared within the network


• All activities are conducted in compliance with relevant external and internal regulations and guidelines (quality, safety, integrity, security and change control). Ensure validation roles and responsibilities are clearly defined and well understood by each site to avoid confusion during audit


• Establish a release management process aligning regulations requirement, user requirements and new software versions to always stay in the support window while minimizing supply disruption.

Required Experience & Competences:

• University degree (Master’s or equivalent) in Computer science


• 10 years’ related management experience in technology related to Manufacturing.


• 10 years’ experience in process Industry and Operational Technology


• 10 years’ experience architecting solutions


• Experience of GXP regulated work within the Pharmaceutical Industry (GXP/GMP, FDA 21 CFR part 11)


• English – Fluent in speaking and writing


• Proven ability to facilitate, manage and lead people in either Project or Line of Business


• Excellent communication skills talking to organization at all levels


• Strong analytical & problem-solving skills


• Proven strong project management experience in the field of Automation/OT//IT systems


• High commitment and result oriented


• Good communication, good leadership, organized & proactive approach


• Innovative mindset


• Customer oriented

Ort

Switzerland HQ - St-Prex