Description
The Biologics MES Deployment Lead is accountable for leading the deployment of Manufacturing Execution Systems (MES) for biologics facilities across the United States.
The role works across engineering, manufacturing, quality, validation, and technology teams to deliver MES solutions that enable safe, compliant, and efficient production.
Key responsibilities:
- Lead MES deployment projects from planning through go-live at biologics sites, coordinating cross-functional teams and external vendors.
- Define system requirements with manufacturing, quality, and engineering partners to support production and compliance needs.
- Co-create the deployment roadmap and value case for MES at biologics sites with the Global MES Lead and Product Owners.
- Challenge existing ways of working to drive standardization and limit the level of customization across deployments.
- Oversee configuration, testing, validation, and release activities to ensure systems meet regulatory and user requirements.
- Develop deployment plans, cutover strategies, training materials, and support readiness activities for site teams.
- Troubleshoot deployment issues on-site and remotely, driving timely resolution to minimize production impact.
- Identify and drive continuous improvement opportunities to enhance MES performance, usability, and integration with other systems.
- Lead your team in using approved AI tools to improve productivity and ways of working.
- Partner with Solution and Enterprise Architects to assess solution options and ensure designs are secure, integrated, scalable, supportable, and aligned with architecture and data standards.
- Coach site teams and junior deployment staff in MES deployment practices and share lessons learned across sites.
- Lead product-level vendor and solution evaluations using transparent, capability-led criteria and contribute to commercial decisions, supplier performance reviews, and lifecycle planning.
- Drive adoption and operational readiness by ensuring business change, training, support models, documentation, release communications, and onboarding needs are reflected in deployment plans.
Basic qualifications:
- Bachelor’s degree in Engineering, Life Sciences, Computer Science, Information Technology, or a related discipline.
- 7+ years of experience delivering Manufacturing Execution Systems (MES) or manufacturing systems within biologics, biotechnology, pharmaceutical, or another regulated manufacturing environment.
- Experience with MES configuration, testing, and validation in a GMP-regulated environment.
- Experience supporting biologics manufacturing processes, including batch records and electronic batch record concepts.
- Experience leading cross-functional teams during MES or manufacturing system deployments.
- Experience coordinating third-party vendors during site deployments.
- Experience developing deployment documentation and training end users.
- Experience integrating MES with manufacturing or enterprise systems.
- Experience with SDLC documentation and validation requirements within a regulated manufacturing environment.
- Experience managing technical projects using formal project management methodologies.
Preferred qualifications:
- Master’s degree in Engineering, Life Sciences, Computer Science, Information Technology, or a related discipline.
- Experience with Emerson DeltaV MES or other commercial MES solutions.
- Experience leading digital transformation initiatives.
- Experience applying automation or approved AI tools to support MES deployment activities.
- Experience with enterprise architecture, systems integration, data, cyber security, validation, service management, and operational resilience.
- Experience evaluating solution cost, value, benefits, risk, and total cost of ownership.
- Experience working with senior functional stakeholders in a matrixed organization.
- Project management, validation, or relevant MES vendor certification or training.