MES Analyst - Mt Vernon - Global Operations AstraZenecaLocation: Mount Vernon, Indiana, United States
Job reference: R-041984
Posted date: Jan. 08, 2019
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 Analyst in Mount Vernon, IN, 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 Analyst will act in a role in the specification, development, testing, implementation and support of the Manufacturing Execution System (PAS-X) in Mt. Vernon. The role holder will work collaboratively with key stakeholders across the business, with Operations IT, and with external partners to ensure that requirements are fully delivered. They will be responsible for the development and maintenance of the PAS-X recipes and the GMP validation lifecycle documentation related to the MES system. They will execute the MES change request process and will perform training, coaching, and business-as-usual duties as required.
System Development and Support
- Gather user requirements for requested changes and additional processes on PAS-X MES.
- Translate business requirements into design specifications, and design specifications into application configuration and code, and ensure requirements are met, tested, and implemented.
- Develop modifications to existing Electronic Batch Records (EBR).
- Assist in the management of contracted development of new EBR recipes.
- Coordinate and perform test script development and testing activities related to the development of new EBR requirements.
- Develop and review 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.
- Implement best practices to create competitive advantage for the site.
- Ensure the solutions developed satisfy the needs of the business.
- 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.
- Ensure project delivery complies with policies and procedures.
- Interact with regulatory agency personnel during audits and inspections.
- Bachelor’s degree required, preferably in Engineering, Computer Science, or other related technical discipline
- Minimum 4 years’ experience in Automation Engineering, IT, or related field
- Experience with Werum PAS-X
- Ability to work and communicate within a global, culturally diverse, and fast-paced team environment
- Strong team working skills
- Evidence of developing innovative solutions
- A proven track record of delivering results
- Excellent verbal and written communication skills
- 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
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.