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Location:
Newark, Delaware, United States
Job reference: R-048426
Posted date: Apr. 04, 2019
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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 Manufacturing Execution System (MES) Specialist in Newark, DE , 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. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

The Supply Planning Process Execution Team (SP PET) is accountable for developing and maintaining the 0 – 36-month supply plan for the site assets as part of the global end to end supply chain.  This requires close collaboration with global planning and site process execution teams to ensure site capabilities are accurately understood, supply plans are well developed and able to be executed, and future targets are meaningful and achievable. 

The SP PET is accountable for:

  • Incoming direct materials planning and supplier management
  • All activities around import/export of materials and relationship management with the associated supply/customer production sites
  • All materials/production data management including MES/EBR
  • Implementation and control of all new/changed packing materials graphics and associated documentation.

The MES Specialist role is critical to the introduction and ongoing support of the PAS-X system to ensure the system is continuing to meet business requirements. As a responsible contributor for the operation, responsibilities must be done while maintaining compliance to CGMP’s and other regulatory requirements, as well as AstraZeneca standards. 

The MES Specialist is responsible for:

  • The development, design and maintenance of PAS-X GMBR, PVL, PMBR
  • Maintaining Master Data in Werum PAS-X system
  • Assisting in developing and documenting process requirements and the associated SOP and process documentation
  • Design, development and upkeep of PAS-X gMBRs, PVLs and PMBRs in conjunction with approved Global templates to accommodate introduction of new products or changes in manufacturing processes.
  • Understands the logic of PAS-X and the integration with other systems. Communicates effectively at all levels to both technical and non-technical audiences pertaining to PAS-X
  • Assist the Materials and Documentation Process Owner in the implementation of PAS-X EBR across packaging and/or formulation PETs at Newark as determined by the site prioritization process. 
  • Provide input as required for PAS-X validation and compliance documentation, including requirements and design specifications, risk assessments, test protocols and scripts, traceability matrices, and validation plans and reports. Executes (or supervises the execution of) IQ, OQ, PV, UAT and PQ.
  • Support PAS-X and SAP compliance initiatives to support IT Policies, GxP, GAMP requirements. Adhere to and provide input to the Master Data Change process used to control and govern changes to PASX master data and MES related SAP data as well ensuring PAS-X and SAP integrated Master Data is aligned and consistent.
  • Works with Materials and Documentation Process Owner and other AZ manufacturing sites utilizing PAS-X to actively promote continuous improvement and assure consistent and simplified ways of working.
  • Provides documentation to the Production areas required to manufacture batches from TDMS and PAS-X. Provide backup support for kitting paper batch records, as needed.
  • Support production issues associated with MES systems to minimize downtime and quality impact.
  • Provide user support for training, account management, and system troubleshooting.

Qualifications:

Education:

  • Bachelor’s degree

Required:

  • Minimum two (2) years' experience in GMP or regulated production environment
  • Demonstrated knowledge of PAS-X System
  • Experience with a PAS-X electronic batch record implementation and continuous improvement initiatives
  • Strong ability to understand process flow, decision points, and IT logic
  • Strong working knowledge of Excel
  • Experience and/or sound knowledge of SAP
  • Attention to detail
  • Strong communication and organizational skills
  • Demonstrated problem solving skills
  • Strong analytical skills

Desired:

  • Knowledge of PAS-X, TDMS, Microsoft applications, SAP, OCM and Microsoft application platforms.
  • Training or experience in packaging technology
  • Knowledge or previous experience in executing technical programs/projects
  • Knowledge or previous experience in validation documentation and execution
  • Minimum five (5) years’ experience in GMP or regulated production environment
  • Knowledge of FDA cGMP’s
  • Experience working in a LEAN manufacturing environment

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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Manufacturing Execution System Specialist - Newark, DE - Global Operations
Supply

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