Gxp Systems Manager
Vor 3 Tagen
A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
**BDC - GxP Systems Manager**You will contribute to the development of the digital strategy and the support of the needs of a new Biotech site. The **Biotech Development Center **(BDC)is our Company´s next **flagship biotech investment** in line with our ambition to become The Vibrant Science and Technology Company and of our Healthcare business sector's strategy to become a **Global Specialty Innovator** and **always better serve our patients.**
For this, you need to understand the complex business needs and assist in defining the solutions to support any future business. You and your team will drive Projects on new technology and manage related change control and will provide proactive support to our key customers' requirements. Ensure the deployment, changes, upgrades and support fore-systemsin compliance with GMP on this systems.
**Your role**:
As part of the digital technologies team and in close collaboration withglobal and local Engineering, Production, IT, and Quality departments (global and local organizations),you and your team will lead thespecification, implementation, qualification and commissioning and operation of GxP systems for a biopharmaceutical development and cGMP clinical production plant.This positionwill help to develop requirements and specifications andengage with external IT and OT solution providers and select fit for purpose technologies.
You willidentify,assessand implement relevant existing and emerging industry and company standards.This role will collaborate with production/QC software vendors and drive standardization of integration options.You will help to develop, implement, and maintain IT/OT integration solutions that enable next level of digitalization maturity in our plant and implement "Connected Plant" (vertically integrated OT Assets and IT Systems).This position will collaborate with the Global team to align the project strategy with the corporate vision.
You will provide proactive support to end-users and serve as a single point of contact to ensure that your customer get the service, they can expect from the GxP systems.
The Site GxP Systems Manager must:
- Lead his team andexternalintegratorstosuccessfullydelveron time and onbugetDigital GxP Systems scope of BDC Project (e.g. CDS, Historian, LIMS, MES, SAP, SDC,...)
- Ensuresuccessfulcommissioning and qualification of all GxPsystemsin BDCprojectscopeworkingcloselywithCQV manager and manager
- Ensuresuccessfulandsmooth transitionfromtheprojectphase to theoperationalphase
- Lead theteam ensuring adequate resources within budget
- Prepare staffing plans and coordinate activities for his team. Be the system owner for some GxP systems.
- Assure maintenance and adequate lifecycle management of the GxP systems under his responsibility
- Drive continuous improvement of the existing GxP systems and processes
- Drive delivery of GxP systems projects as part of system lifecycle and site expansions
- Drive integration of stand-alone devices to middleware or management platforms.
- Drive creation of requirement, design, procedure, and validation documentation
- Ensure technical competency of his team and ensure the team maintains up-to-date skills and capabilities through training
- Ensure adequate SLAs with internal and external suppliers (incl. IT department)
- Prepare annual budget plans for his perimeter of activities (CAPEX and OPEX)
**Whoyouare**:
- MSc or BSc Graduate in Computer Science or Engineering (Digital, automation, robotics,)or equivalent.
- You have 7+ years of professional experience in IT or Engineering
- You have led teams and system integrators (5+ years)
- You are familiar with cGMP guidelines and regulations for computerized systems (3+ years)
- Knowledge of IT/OT infrastructure, connectivity, data integrityand cyber security.
- Biotech industry experience in a GMP environment is strongly preferred. Ability to engage people in a matrix organization.
- Service oriented, emotional intelligence as well as ability to navigate into complex organization and create networks isa valuable asse
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