MES Business Analyst job in Newark
|Employer:|| AstraZeneca Pharmaceuticals|
At AstraZeneca we believe in the potential of our people and you'll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. |
The Manufacturing Execution System (MES) Business Analyst has experience performing IT business analysis within a multi-system manufacturing environment, working with key business partners. The role holder has a broad and deep understanding of manufacturing business processes, and can drive standard best practice approaches to implementation across multiple pharmaceutical and biologics production technologies at facilities with diverse geographies, regulatory requirements, and cultures.
The MES Business Analyst will be accustomed to adapting to a variety of complex scenarios within plants where manufacturing processes and equipment differ, and be able to work strategically keeping the enterprise solution in mind. The MES Business Analyst operates with a high level of interactive communication to set clear direction for others, demonstrating high levels of inclusion and cultural sensitivity.
The role will partner with the local and global Business Process Owners (BPO) of the Manufacturing Execution process. In this partnership, the MES Business Analyst will be an active member of governance boards, supporting the BPO in driving the adoption of standard AstraZeneca processes across the manufacturing site network.
The MES Business Analyst will take a best practice approach to process documentation, maintaining a comprehensive set of standard and site process flows (ex: swim lane diagrams). They will also work closely with the manufacturing architects and engineering so that the business processes deployed in MES are underpinned with the appropriate technology, and the users' needs are supported.
The MES Business Analyst will be an active participant in an MES Center of Excellence. In this role they will closely collaborate with other site based MES specialists, informing on Master Batch Record / Generic Master Batch Record (MBR/GMBR) standard methodology design principals. The design principals will align with the standards established by both the MES BPO and Quality MBR BPO standards.
The MES Business Analyst is expected to perform at experienced level in the following:
Business Needs Identification - Operates at an enterprise level in assessing and defining business need and areas for improvement. Actively seeks out opportunities to enhance and improve in line with strategic goals. Actively monitors and identifies capability gaps and proposes potential solutions through research internally and externally.
Business Process Mapping - Selects the appropriate documentation approach depending on process type. Proficient in scoping and recommending appropriate approaches. Capable of planning and leading their own and other team members' activities to meet targets and deadlines. Accountable for performance and quality of analytical work delivered, both their own and the work of others.
Partner Analysis & Change - Effectively identifies partners from all areas of the business, and actively builds and maintains relationships according to individual partner needs and levels of influence. Contributes to communication plans and change management for project and partners.
Business Solution Assessment - Highly proficient in analyzing and assessing solution proposals and able to articulate supporting reasoning. i.e. assessing business readiness, improving value vs. spend. Leads the work with the business to identify functional and technical and GMP compliance requirements, translating the requirements into design specifications reflecting Functional Design, User Interface Design and Business Process Modelling. Closely partnering with the Architecture team, ensuring the technical solution will deliver the agreed business benefits.
Manufacturing and Packaging Processes - Has a diverse set of experiences with shop floor manufacturing environments, preferably in the Pharmaceutical, Biologics or life sciences sector. Understands the importance of the user's role in executing the manufacturing process, their interaction with electronic systems, and the constraints they face when performing their duties.
Work collaboratively with:
1. Senior Business Stakeholders to ensure that solutions fulfil their future strategic needs and challenges
2. Business Process Owners to develop and maintain the business relationship, support business process change and act as point of contact for MES deployment and change
3. Site Business customers to identify business needs, mentor local MES staff, and effectively communicate impact, cost and benefits of new and changed demands
4. IT Delivery and Support to ensure clear understanding of requirements and effective testing so that the solutions delivered to the business are efficient and effective, meeting the customer experience expectations.
5. Site and Global Engineering Teams to ensure that specified line equipment is able to integrate seamlessly with the AstraZeneca standard solution for MES
Work collaboratively with or take responsibility for:
6. Test Lead to define the testing approach and the components of testing to ensure traceability of requirements and effectiveness of overall solution.
7. Change Management/Communication Lead to ensure the Change Management and Communications plans and delivery support the Partner Analysis.
Education, Qualifications, Skills and Experience
•Validated experience of working with complex integrated systems, using creative and strategic thinking to deliver extraordinary results.
•Strong engagement, communication and partner management skills, including excellent presentation and influencing skills at senior levels
•Experience of mentoring, coaching or developing others
•Experience of working with and managing third party suppliers/vendors
•Experience of running high levels of risk by making reasoned judgements of complex situations, developing creative solutions and applying comprehensive multi-functional and industry understanding.
•Experience with Manufacturing Execution Systems
•Experience with production processes within Enterprise Resource Planning systems such as SAP
•Degree in relevant engineering or IT discipline
•Exposure to User Centred Design (User Experience, User Interface and Business Process Engineering)
•Lean SIGMA training
•Practical usage of Agile Methodology
•Experience of working in a global organisation with complex/geographical context
•Working in a highly regulated industry
•Pharmaceutical business awareness
•Cross industry business awareness
•Demonstrable experience of successfully deploying MES technology in a regulated manufacturing environment
•Through understanding of industry standards for enterprise and control system integration such as ISA95 and S88
•Experience with production automation systems
•Experience with the Werum PAS|X MES system
•Experience with Data Historian Systems
Internal (to AZ or team)
•IT Capability Leads
•Business Relationship Managers
•Global process and systems owners
•Enterprise and Solution Architecture
•Strategy, Innovation, Delivery and Capability functions
•Capability Service Managers and Operational Service Managers
•Multi-functional project teams
•Internal network forums
External (to AZ)
•External IT partners, Third Party suppliers/vendors
•MES professional bodies, networks and forums
•Business specialism professional bodies, networks and forums
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender 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.