Hamlyn Williams | Automation Engineering Manager | wilson, nc

2 weeks ago

wilson, United States Hamlyn Williams Full time

We represent our client, a leading global biopharmaceutical company, in their search for an Automation Engineering Manager.


This role is pivotal in shaping and supporting their cutting-edge facility's highly automated manufacturing processes.


The successful candidate will lead the design, support, and maintenance of the site's Delta V systems, ensuring compliance with regulatory standards and advancing automation solutions to optimize production efficiency.


Key Responsibilities

  • Automation Support & Compliance: Manage automation systems, configure interfaces, ensure compliance with regulatory and company standards, and support validation protocols and risk assessments.
  • Delta V Strategy & Execution: Define and implement the Delta V strategy, ensuring the right resources, processes, and capabilities are in place to meet project and operational goals.
  • Project Leadership: Oversee improvement projects related to the Delta V system, tracking cost, quality, and schedule to ensure successful execution.
  • Collaboration & Communication: Establish strong working relationships with Quality, IT, Lab Systems, Procurement, and other key departments, while providing senior-level communication to remove obstacles.
  • Performance Monitoring: Define and monitor performance metrics and KPIs for Delta V systems.
  • Lifecycle Management: Lead the Delta V team to deliver on key projects, system upgrades, and lifecycle management initiatives.
  • Technical Ownership: Serve as the site's Delta V Infrastructure Technical Owner and system SME, managing vendor relationships and identifying continuous improvement opportunities.


Qualifications

Required:

  • Bachelor’s Degree in Engineering, Science, or a related discipline.
  • Minimum 6 years of experience in a manufacturing environment, preferably in biopharma or pharmaceutical industries.
  • At least 2 years of experience in a GMP-regulated climate in an Execution Systems, Automation, or IT role.
  • Strong technical knowledge of Emerson Delta V, OSI Pi, PLCs, IT infrastructure, and hardware.
  • Experience with MES (preferably Werum PAS-X) and Delta V Batch Control.
  • Familiarity with industrial automation networks, communication protocols, and ISA S95 & S88 standards.
  • Knowledge of cGMP regulations, including 21 CFR Part 11 and EU GMP Annex 11.


Preferred:

  • Experience supervising/managing people and resources.
  • Project management certification and experience.
  • Process knowledge for upstream, downstream, and bio-processing functions.
  • Familiarity with GAMP 5 and industry-standard methodologies.
  • Understanding of Industry 4.0/IoT and the digital transformation of biopharma.


Why Join?

This is a unique opportunity to play a critical role in an advanced manufacturing environment that leverages cutting-edge automation to support the delivery of life-changing therapies. You’ll join a collaborative team where your expertise and leadership will drive innovation and operational excellence.


Ready to Take the Next Step?

Apply now or contact us for more details about this exciting role. Let’s shape the future of biopharma manufacturing together

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