AD, MES Manufacturing Automation Engineer (Hybrid - Durham, NC)

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in our manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to a globally spanning manufacturing supply chain to ensure the highest quality of raw materials, intermediates and finished products.

GENERAL SUMMARY:

Our Digital Manufacturing Operations (DMO) Senior IT Specialist - Manufacturing Automation (MES Engineer) is responsible for supporting the Manufacturing Execution Systems (MES) that directly support the Maurice R. Hilleman Vaccine Manufacturing Facilities (our Manufacturing Division, Durham), while actively participating in and embracing an empowered team culture.

The Sr. Specialist will lead a small elite team of like-minded Subject Matter Experts (SME) specific to our Manufacturing Division Durham supporting the MES application and its operational use in manufacturing production. The Sr. Specialist will partner with site manufacturing and automation leads, as well as corporate IT groups, to support multiple MES environments.  The Sr. Specialist will be required to understand and promote IT strategies and initiatives as they relate to the MES environments.

GENERAL PROFILE:

• Our Digital Manufacturing Operations Senior IT Specialist - Manufacturing Automation (MES Engineer) must be able to work independently and be comfortable reaching across functional and geographical areas to collaborate with IT colleagues, third party solution providers and contractors.

• Work flexibly and collaboratively as a team leader or supporting personnel in an inclusive, dynamic operating environment.

• Works in an empowered, self-directed culture with independent decision making in the planning, coordination, and execution of multiple activities and projects.

• Maintaining an active dialog and communicating between affected departments and leadership to ensure project progress and milestone success.

• Responsible for effective document review, approval, and conformance to our Company Manufacturing Standards, our Manufacturing Division Quality Policies, cGMPs for the generation and approval of the required documentation and testing.

• Develops, reviews, and approves site procedures and reviews updates to divisional guidelines.

• Responds to divisional initiatives and Quality Directives.

• Analyzes and solves problems using standard problem-solving processes.

• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.

• Provides training sessions to our Company personnel pertaining to MES requirements.

BUSINESS EXPERTISE:

• Understands the fundamental business drivers for the company; and uses this knowledge in own work.

• Understands and applies regulatory / compliance requirements.

FUNCTIONAL EXPERTISE:

• Our Digital Manufacturing Operations Senior IT Specialist - Manufacturing Automation (MES Engineer) responsibilities include:

• Provide 24 x7 on-call support for MES operational and system issues as a member of a rotating support group.

• Manage and perform change controls according to site procedures for master data and MES system parameters.

• Partners with corporate IT teams to resolve complex issues and ensure proper root cause is identified and preventative actions are implemented.

• Collaborate with MES Engineers at other sites to share best practices and discuss common issues.

• Creating and maintaining alignment between Master Batch Records (MBRs) and corresponding SAP Production Variant and DeltaV recipes.

• Maintaining the MES in compliance with Current Good Manufacturing Practices  (cGMPs). 

• Perform System Life Cycle upkeep of new and existing MES environments in accordance with Computer Software Assurance (CSA)

• Lead the definition, SDLC documentation and validation of new master data and system parameters as a member of a team responsible for new products/MBR’s.

• Lead the definition, SDLC documentation and validation of master data and system parameters changes required for MES system upgrades.

• Reviewing MES system and SDLC documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety.

• Developing and supporting corrective actions for investigations related to MES.

• Participation in Kaizen events.

• SOP dev