MES Process Champion - Mount Vernon, IN - Global Operations

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a MES Process Champion in Mount Vernon, Indiana, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world ? 20% of our global workforce. With 30 production facilities in 18 countries we're focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that's full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.
The MES Process Champion will act in a leadership role in the specification, development, testing, implementation and support of the Manufacturing Execution System (Pas-X) in Mt. Vernon.
Responsibilities include but are not limited to the following:
Work collaboratively with key stakeholders across the business, with Operations IT, and with external partners to ensure that requirements are fully defined, prioritized and delivered.
Accountable for the development and maintenance of the Pas-X recipes GMP validation lifecycle documentation related to the MES system.
Lead the governance of MES change requests and will perform training, coaching, and business-as-usual duties as required.
System Governance
Contributes to the development and implementation of business strategies related to the Pas-X System and Level 2 Process Control system integrations
Partners with Process Execution Teams to prioritize and implement modifications and upgrades to improve quality and operational effectiveness of existing systems.
Gather user requirements for requested changes and additional processes on Pas-X MES; Map existing manufacturing processes to MES.
Develop modifications to existing Electronic Batch Records
Manage contracted development of new EBR recipes.
Lead test script development and coordinate testing activities related to the development of new EBR requirements
Review and approve documentation needed for qualification of equipment and processes
Support the validated status of the system throughout the lifecycle by ensuring appropriate change management processes are followed and all relevant GMP documents are maintained.
Develops and cultivates technical expertise and knowledge within the site and across the MES global community by disseminating best practices and sharing knowledge across functions.
Implements best practices to create competitive advantage for the site.
Serves as subject matter expert during projects, internal audits and regulatory inspections.
Business Process Governance
Work collaboratively with key users to improve master data accuracy
Generate reports to support key stakeholders within the business
System Support
Develop and maintain support model for MES to meet the growing usage and reliance on the system
Develop and maintain relationship with key vendors and contractors for recipe development and project delivery
Support/Train super users in the support model for the MES system
Act as a line of contact/escalation point in the support model by providing business hours and on-call support for MES systems in coordination with super users, Automation resources, and IT personnel per defined escalation processes.
Support periodic disaster recovery testing and technical system upgrades as required.
Other Duties:
Ensure project delivery complies with policies and procedures
Interact with regulatory agency personnel during audits and inspections
Monitor key performance indicators to meet strategic goals.
Bachelor's degree required, preferably in Engineering, Computer Science, or other related discipline.
Minimum four years' experience in Automation Engineering, IT, or related field.
Project management experience and proficiency.
Ability to work and communicate within a global, culturally diverse, and fast-paced, team environment.
Strong influencing, networking and team working skills.
Evidence of leading and developing innovative solutions.
Able to manage negotiations, expectations and solutions across complex groups.
A proven track record of delivering results.
Experience in the pharmaceutical or biotechnology industry is desired.
Sound understanding of Good Manufacturing Practice, Safety, Health and Environment and Standard Operating Procedures
Knowledge and understanding of validation and qualification principles, project management, and change control principles.
PMP certification desired
Experience with Werum Pas-X
Next Steps ? Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience ? it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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