Senior MES & GxP Ops Leader — On-Site, Equity Eligible

Vertex Inc.; Boston (MA); On-site; USD 162,000 - 242,000; Full time

Job summary

Vertex Inc. seeks an Associate Director, GxP Operations Support Manufacturing Systems to lead the design, delivery, administration, and continuous improvement of MES and manufacturing control systems for clinical and commercial operations on-site in Massachusetts.

You will partner across Manufacturing, Quality, IT, and Engineering to ensure compliant, reliable systems and drive digital manufacturing capabilities.

Qualifications

• Bachelor’s degree in Engineering, Information Systems, Biotechnology, or a related technical discipline.
• Minimum 8 years of progressive experience in manufacturing, automation, MES implementation, or manufacturing systems engineering within a GMP pharmaceutical/biopharmaceutical industry.
• Proven track record leading cross-functional initiatives and delivering business-critical system implementations.
• Strong knowledge of GMP regulations, Computer Software Assurance, Data Integrity principles, and 21 CFR Part 11 requirements.

Responsibilities

• Develop and execute the strategic roadmap for MES and manufacturing digitalization initiatives supporting clinical and commercial manufacturing operations.
• Collaborate with Manufacturing, Quality, IT, and Engineering stakeholders to identify, plan, prioritize and implement business process improvements through digital system capabilities.
• Brings deep knowledge of foundational automation engineering concepts to guide MES strategy and solution design including modular builds, workflow orchestration, equipment integration, electronic data capture, analytics, and reporting.
• Drive standardization and best practices to improve reliability, scalability, and supportability.
• Ensure deployment and lifecycle management through system administration, configuration management, cybersecurity assurance, and backup and recovery planning.
• Establish and monitor KPIs to measure system performance, adoption, reliability, and business value.
• Foster a culture of innovation, accountability, collaboration, and continuous improvement among MES team members, end users and the network of stakeholders.
• Provide technical coaching and leadership to support team member development, complex project execution, and operational excellence.

Skills

Strategic leadership

Communication

Stakeholder management

Organizational leadership

GxP knowledge

Education

Bachelor’s degree in Engineering/IS/Biotech

Advanced degree preferred

Tools

POMSnet MES

SCADA

Historian platforms

Job description

Vertex Inc. seeks an Associate Director, GxP Operations Support Manufacturing Systems to lead the design, delivery, administration, and continuous improvement of MES and manufacturing control systems for clinical and commercial operations on-site in Massachusetts.

You will partner across Manufacturing, Quality, IT, and Engineering to ensure compliant, reliable systems and drive digital manufacturing capabilities.