• United States Of America, Usa

Job Description:

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 Were 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, youll 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 PERCENT of our global workforce With 30 production facilities in 18 countries were 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 thats 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

Job Responsibilities

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

Other duties

Ensure project delivery complies with policies and procedures
Interact with regulatory agency personnel during audits and inspections

Qualifications

Education

Bachelors degree or 5 years of relevant industry experience required, preferably in Engineering, Computer Science, or other related technical discipline

Required

Minimum 2 years experience in Automation Engineering, IT, or related field
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

Desirable

Experience with Werum PAS-X
Experience in the pharmaceutical or biotechnology industry
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

Manufacturing Execution System (MES) Analyst - Mt Vernon - Global Operations

Information Technology

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 20th Feb 2020

Key Skills:

Company Profile:

Company
ASTRAZENECA PHARMA INDIA LTDarfix

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