Senior Manager – Manufacturing System Engineering

Job Title:

Senior Manager – Manufacturing System Engineering

Location:

Holly Springs, NC (100% Onsite)

Job Summary

Our client is seeking an experienced Senior Manager – Manufacturing System Engineering to support the startup and long-term operation of a new biopharmaceutical manufacturing facility. This individual will lead the site's Automation Engineering function while partnering with Corporate Engineering during facility design, construction, commissioning, qualification, and startup. The ideal candidate will provide both technical leadership and people management, ensuring reliable manufacturing operations, regulatory compliance, and continuous improvement in a GMP-regulated environment.

Key Responsibilities

• Build, lead, mentor, and develop the site Automation Engineering team.
• Serve as the primary technical lead for automation systems and manufacturing process control.
• Partner with Corporate Engineering throughout facility design, construction, commissioning, qualification, and startup activities.
• Participate in design reviews and provide technical guidance on automation architecture and process control strategies.
• Support commissioning, qualification, and validation (CQV) activities for automated manufacturing systems.
• Develop and maintain automation solutions using Emerson DeltaV Distributed Control Systems (DCS).
• Execute Automation Installation Verification (IV) and Automation Checkout (ACO) activities.
• Collaborate with Manufacturing, Process Engineering, Quality, Validation, and Maintenance teams to support operational readiness.
• Provide day-to-day automation support, troubleshoot manufacturing systems, and participate in on-call support for manufacturing operations.
• Manage automation system administration, operating system lifecycle, Hot Fix assessments, preventive maintenance, spare parts, and departmental SOPs.
• Support change control, deviation investigations, engineering studies, and process qualification activities.
• Lead continuous improvement initiatives to improve system reliability, safety, and manufacturing efficiency.
• Ensure compliance with GMP regulations, data integrity requirements, and company quality standards.
• Represent Automation Engineering during inspections, audits, and cross-functional reviews.
• Manage departmental budgets, resource planning, and engineering priorities.

Required Qualifications

Candidates must meet one of the following:

• High School Diploma/GED with 12+ years of engineering experience, or
• Associate's Degree with 10+ years of engineering experience, or
• Bachelor's Degree with 8+ years of engineering experience, or
• Master's Degree with 6+ years of engineering experience, or
• Doctorate Degree with 2+ years of engineering experience.

Additionally:

• Minimum 2 years of people management or technical leadership experience leading teams, projects, or programs.
• Experience supporting manufacturing automation within a regulated pharmaceutical or biotechnology environment.