Principal Manufacturing Systems Engineer
The Principal Manufacturing Systems Engineer will lead the design, implementation, and optimization of advanced manufacturing systems across global production sites. This role is critical to ensuring the scalability, reliability, and compliance of our manufacturing operations, supporting both clinical and commercial product pipelines. The ideal candidate will bring deep expertise in manufacturing automation, data integration, and systems engineering within a regulated biotech or pharmaceutical environment.
Key Responsibilities
- Lead cross-functional initiatives to design and deploy integrated manufacturing systems (MES, ERP, SCADA, LIMS) that support GMP operations.
- Serve as the technical authority for system architecture, data flow, and automation strategies across global sites.
- Collaborate with IT, Quality, and Process Engineering teams to ensure seamless integration of digital systems with manufacturing processes.
- Drive continuous improvement initiatives focused on system performance, data integrity, and operational efficiency.
- Oversee validation and qualification activities for new systems and upgrades, ensuring compliance with FDA, EMA, and other regulatory standards.
- Mentor and guide junior engineers, fostering a culture of technical excellence and innovation.
- Stay abreast of emerging technologies and industry trends to inform strategic planning and system evolution.
Qualifications
- Bachelor's or Master's degree in Electrical Engineering, Chemical Engineering, or related field; PhD preferred.
- 10+ years of experience in manufacturing systems engineering within the biotech, pharmaceutical, or life sciences industry.
- Proven expertise in MES platforms (e.g., Werum PAS-X, Emerson Syncade), automation systems (PLC, SCADA), and enterprise integration (SAP, Oracle).
- Hands-on experience with DeltaV Distributed Control Systems and Rockwell Automation platforms is required.
- Strong understanding of GMP, GAMP 5, and validation principles.
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