MES Specialist PC 1611

Miltenyi Biomedicine•Gaithersburg, MD

17h

About The Position

This position is in the Manufacturing Science and Technology team (MS&T) team. We are seeking a knowledgeable and proactive MES Specialist to support implementation and enhance our Manufacturing Execution System (MES) within a GMP-regulated manufacturing environment. This role requires sound technical skills in design/configuration/testing/validation of workflows / electronic batch records within our MES along with excellent problem-solving and communication abilities. This role plays a key part in digitalizing GMP manufacturing processes and enhancing operational efficiency through well-structured and compliant MES workflows. Additionally, this position will collaborate closely with internal and external stakeholders establishing partnerships to ensure compliance with cGMP and Quality Management systems to deliver our services to the clients effectively.

Requirements

A BS/MS degree in automation, industrial IT, engineering or a related field; At least 2 years of related experience in manufacturing execution systems and relevant software platforms.
Demonstrated experience in pharmaceutical or regulated manufacturing environments.
Experience in implementing GMP manufacturing processes into MES workflows, with the ability to perform testing, documenting test conditions, and workflow validation related to MES system.
Understanding of database systems and programming languages is advantageous.
Technical support experience to diagnose and resolve MES software and integration issues.
Experience in handling Quality Events (QEs) in the quality system.
Meticulous and logical in configuring, testing, documenting, and delivering MES solutions.
Flexible in dynamic environments; effective in prioritizing tasks and managing projects.
Excellent oral and written communication skills with technical writing ability
Ability to work effectively with cross-functional teams and stakeholders.
Project management skills including planning, execution, risk and change management
Effective team player with analytical and problem-solving skills
Good knowledge of Microsoft office
Work with operations team to create a culture of accountability, ownership, and continuous improvement
Job duties may include after hours on call support.
Work across departments and/or sites.
Work with process engineers and manager to align the priorities of the team with those of the department
Able to work independently; shows initiative and able to work with all levels of staff.

Responsibilities

Support the lead engineer in the design, testing, validation, and implementation of MES workflows and master batch templates per GMP requirements.
Support Integration of MES workflows with related systems such as ERP and manufacturing equipment into the MES workflows.
Create and maintain technical documentation like manuals, operating procedures, validation test cases for MES workflow configurations and related systems.
Own and manage timely completion of MES related Quality Events (QEs) such as deviations, investigations, CAPAs, and Change Controls in the quality system.
Work in a cross-functional matrix environment, including Manufacturing, Quality Assurance (QA), Quality Control (QC), and Information Technology (IT) to understand requirements and implement MES solutions.
Provide technical support for the MES platform by offering training and on call support to plant personnel.
Maintain continuous coordination and communication with internal stakeholders and report regularly to the MES System Owner.
Ensure MES designs adhere to GMP regulations and data integrity standards (21 CFR Part 11).