AstraZeneca Pharmaceuticals LP MES Process Champion - Global Operations in West Chester, Ohio
The MES Process Champion will act in a leadership role in the specification, development, testing, implementation, and support of the manufacturing execution system at the West Chester site.
The role holder will primarily be accountable for the design, deployment, and upkeep of Equipment Management and EBR at the West Chester site.
This role holder will work collaboratively with key stakeholders across the business, and with external partners, to ensure that requirements are fully understood, defined and support the business needs.
The role holder will support the development and maintenance of Master Data related documentation, both GMP and non-GMP related, including all documents relevant to the lifecycle of MES.
The role holder will support the governance of MES, which will include providing support for identifying and delivering improvement initiatives, providing support to train and coach appropriate personnel, and to provide assistance to perform Business-As-Usual duties when required.
Essential Job Functions:
Gather user requirements in relation to controlling and recording manufacturing activities
Map existing manufacturing process (warehouse, equipment management & EBR) to MES
Assess manufacturing processes and develop/configure Electronic Batch Records (EBR)
Design and deploy MES systems to replace paper based or manual systems in a pharmaceutical environment
Document MES configuration
Develop into a Subject Matter Expert during projects incorporating system content
Support the definition of Test Use Cases and development of Test Scripts
Participate in User Acceptance Testing and validation activities
Support the validated status of the system, throughout the lifecycle, by application of appropriate change management techniques
Business Process Governance:
Develop and maintain business processes
Translate system design into local business process documents (e.g Standard Operating Procedures, Work Instructions)
Support the development of training material
Support and lead the delivery of end-user training
Master Data Management:
Execute master data generation/maintenance tasks for the various systems
Work collaboratively with key users to improve master data accuracy
Generate reports to support key stakeholders within the business
Act as a line of contact/point of escalation in the support model
Review the performance of the system using data to identify areas for improvement
Provide guidance for problem resolution
Read, understand, and comply with cGMP (Good Manufacturing Practices), Standard Operating Procedures and Safety procedures
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.
Review and approve documentation needed for qualification of equipment and processes.
Bachelor of Science Degree in Engineering or related technical discipline
5 years of experience supporting manufacturing operations in a regulated or cGMP environment.
Prior experience with Pas-X or other MES system
Prior project management experience
Previous experience in a sterile pharmaceutical environment.