Principal Systems Engineer for Pharmaceutical Manufacturing

5 days ago


Durham, North Carolina, United States BioSpace, Inc. Full time
Job Title: Principal Systems Engineer for Pharmaceutical Manufacturing

Job Summary:

As a Principal Systems Engineer for Pharmaceutical Manufacturing at BioSpace, Inc., you will be responsible for the deployment and continuous improvement of the Manufacturing Execution System (MES) at our RTP site. This role will require technical mastery of MES for drug product operations and cross-functional collaboration to expand the MES footprint as part of the overall site ramp up.

Key Responsibilities:

* Provide technical leadership to deploy MES Electronic Batch Record (EBR) and associated ancillary electronic tickets to new manufacturing lines in 2025-2026.
* Collaborate with cross-functional business partners in Supply Chain, Engineering/Process Automation, Quality, Operations, Learning & Development, and global counterparts to ensure integration of MES with existing site intralogistics system for automated material movement.
* Foster a continuous improvement culture through identification and adoption of process improvements, both in EBR design and MES support processes.

Requirements:

* Bachelor's Degree in IT, Engineering or related discipline.
* 7+ years' experience in IT and/or Engineering Automation/control systems related fields.
* 5+ years' experience with design, development, testing, delivery, support of Electronic Batch Record(s) using Rockwell PharmaSuite.

Preferred Qualifications:

* Experience with design, development, testing, delivery, support of Electronic Batch Record(s) using Rockwell PMX.
* Previous experience supporting drug product and packaging manufacturing operations for human health pharmaceuticals.
* Understanding of ISA-95 network infrastructure and internal DMZ

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