Manufacturing Execution System (MES) Specialist
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Newark, DE 19713
Kelly Services currently has an opportunity for an MES Specialist at a prestigious global biopharmaceutical company, located in Newark, DE
Job Title : Manufacturing Execution System (MES) Specialist
Duration : 1 year
Pay Range : $35-$42/Hour
FUNCTIONAL AREA DESCRIPTION
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 also 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.
IMPACT OF THE ROLE ON THE BUSINESS
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.
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
As a responsible contributor for the operation, this must be done while maintaining compliance to CGMP’s and other regulatory requirements, as well as company standards.
In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title:
+ 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 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.
+ Bachelor’s degree
+ 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
+ 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
Important information : This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please apply online or contact firstname.lastname@example.org for immediate consideration
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AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .
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Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
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