Specialist, Manufacturing Automation MES (Hybrid - West Point, PA)

Job Description

The Manufacturing Execution System (MES) Specialist acts as a subject matter expert and an area(s) site MES key point of contact, for Operations areas utilizing electronic Master Batch Records. The MES Specialist’s primary responsibility is to ensure that the deployment of the Korber PAS-X electronic Master Batch Records are successfully and compliantly designed, developed, deployed, and supported to maximize business benefits and are in line with site business process and technical standards. The MES Specialist will have regular direct interaction with site COMET Data Center of Excellence (CoE), Tech Ops, Operations, Quality, and IT plus collaborate with the above site MES Product Team. The MES Specialist will also be accountable for SAP-MES data integration, along with driving MES training, collaboration, benefit realization, and standardization across the site. The Specialist is responsible for following standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes.

Under the management and supervision of the MES Lead, the MES Specialist is responsible for activities that include the following:

• Assure MES and electronic batch records meet ongoing and future manufacturing requirements and is configured to align with regulatory requirements.

• Ensure MES and electronic batch records align with our Company business processes and technical standards.

• Responsible for supporting MES and electronic batch records implementations across full systems lifecycle.

• Identifying business and technical needs of users.

• Determining appropriate implementation of MES technology, executing implementation and maintaining ongoing operations.

• Uses existing procedures to solve routine or standard problems.

• Performs MES training of end users, such as Operations, Technology, Quality, as needed.

• Participate in MES on-call support 24x7 on a rotational basis.

• Builds own team effectiveness skills and promotes team effectiveness through own actions by demonstrating respect and appreciation for diverse perspectives.

• Assist inspections as needed.

FUNCTIONAL EXPERTISE:

• Detailed knowledge of Korber PAS-X MES application (v3.1.8) to enable production execution, including interfaces for ERP and DCS.

• Partner with site users and project teams to meet their needs through MES and electronic batch record configuration.  This includes active participation in the configuration of MES and batch records, then hands-on shop floor training and implementation which may require periodic shift and weekend support.

• Maintain MES as it relates to PAS-X system configuration, SLC, validation development/execution, hardware, software environments, SOPs and business processes.

• Collaborate in a network with other MES Subject Matter Experts to ensure that best practices are shared and resolve MES related investigations. Where required, participate in MES user groups within our Company to continuously improve the application and associated use practices.

• Collaborate on occasion directly with MES Center of Excellence (CoE).

PROBLEM SOLVING:

• Uses existing procedures to solve routine or standard problems.

• Applies limited judgment and discretion.

INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:

• Responds to standard requests from clients and/or customers.

IMPACT:

• Errors on the job may cause production delays and impact the work of others in own work group.

• Communicates information, asks questions and checks for understanding.

• Has limited decision-making authority; works within technical guidelines and direction to achieve objectives and meet deadlines.

• Accountable for technical contribution to project team or sub-team.

EDUCATION:

• High School Diploma required.

REQUIRED QUALIFICATIONS:

• 1 year of experience in an operations, quality, or technical role within the pharmaceutical and or life science industry.

• Experience in technical writing or requirements, protocols, and test plans.

• Excellent written and oral communication skills.

• Excellent facilitation, problem solving and decision-making skills.

Preferred:

• Knowledge of integrated Manufacturing Execution Systems.

• Understanding of cGMP, and Process Automation System Life Cycle methodologies.

• Bachelor’s Degree in Engineering, Computer Science or other technical