MES Specialist - Newark, DE | Biospace
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MES Specialist

AstraZeneca Pharmaceuticals LP

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Location:
Newark, DE
Posted Date:
6/25/2017
Position Type:
Full time
Job Code:
R-007983
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location:Newark, Delaware, United States
Job reference: R-007983

Posted date: May. 22, 2017



MES Specialist

At AstraZeneca every one of our employees makes a difference to patient lives every day. Each and every one of us believes that science has the ability to change lives and that to deliver this takes many people with many skill sets. When we deliver a life-changing medicine, that success comes from the combined efforts of all of our people. As a 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.

Main Duties and Responsibilities

The MES Specialist role is critical to the implementation, support, and evolution of the PAS-X MES system to ensure the system meets business requirements and delivers incremental business benefit, while aligning with the global MES solution template.

The MES Specialist is responsible for:

  • Partnering with the site’s production functions, Quality Assurance, and IT to drive the development, design and maintenance of PAS-X MES functionality
  • Providing user training and first-level support to the users in their daily use of the PAS-X MES
  • Maintaining Master Data in the PAS-X MES and/or SAP
  • Assisting in developing and documenting process requirements and the associated Standard Operating Procedures and other process documentation to assure the proper integration of MES with site business processes
  • Engaging with the global network of supply sites and IT to ensure MES solutions are standardized, and to ensure system enhancements are appropriately prioritized, designed, and delivered

As a responsible contributor for the operation, this must be done while maintaining compliance to CGMP’s and other regulatory requirements, as well as AstraZeneca standards.

  • Design, develop and maintain PAS-X functionality in conjunction with approved Global templates to accommodate introduction of new products or changes in manufacturing processes.
  • Perform highly complex work activities to understand the logic of PAS-X and the integration between PAS-X and SAP and other IT platforms.
  • Absorb complex technical information and communicates effectively at all levels to both technical and non-technical audiences.
  • Support the Materials and Documentation Process Owner in the implementation of the PAS-X MES across the Newark supply site as determined by the site prioritization process.
  • Provide input to documentation as required for PAS-X validation and compliance, including requirements and design specifications, risk assessments, test protocols and scripts, traceability matrices, and validation plans and reports. Execute (or supervise the execution of) IQ, OQ, PV, UAT and PQ test scripts.
  • Support PAS-X and SAP system compliance to IT Policies, GxP, GAMP and computerized system validation policies and principles.
  • Adhere to and provide input to the Master Data Change process used to control and govern changes to PAS-X master data and MES related SAP data as well ensuring PAS-X and SAP integrated Master Data is aligned and consistent.
  • Work with Materials and Documentation Process Owner and other AZ manufacturing sites utilizing MES (PAS-X) to actively promote continuous improvement and assure consistent and simplified ways of working.
  • Provide documentation to the Production areas required to manufacture batches from TDMS and PAS-X.
  • Support production issues associated with MES systems to minimize downtime and quality impact.
  • Provide user support for training, account management and first line of system troubleshooting.

Requirements

Essential Requirements

  • Bachelors degree
  • Minimum 5 years experience in GMP or regulated production environment
  • One to three years previous project team experience
  • Strong ability to understand process flow, decision points, and IT logic
  • Knowledge of FDA cGMP’s
  • Experience working in a LEAN manufacturing environment
  • Strong communication and organizational skills
  • Demonstrated problem solving skills
  • Strong analytical skills
  • Strong working knowledge of Excel
  • Experience and/or sound knowledge of material creation and SAP MM, BOM, and recipe business processes
  • Attention to detail
Desirable Requirements
  • Knowledge of TDMS, Microsoft applications, SAP, OCM and Microsoft application platforms.
  • Training or experience in packaging technology as deployed at AZ sites
  • Knowledge or previous experience in executing technical programs/projects
  • Knowledge or previous experience in validation documentation and execution

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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.