Digital Core Deployment Lead

Posted Yesterday
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Rensselaer, NY, USA
Hybrid
Expert/Leader
Information Technology • Consulting
The Role
Lead end-to-end deployment of a validated Digital Core template into a US-based biopharma manufacturing process area. Own integrated schedules, site readiness, testing/validation, go/no-go decisions, and coordination between global template teams and local site stakeholders. Ensure GMP and CSV/CSA compliance, manage risks/dependencies, document lessons learned, and improve the deployment playbook for repeatable rollouts.
Summary Generated by Built In

Our client, A large biopharma organization, is looking for a Digital Core Deployment Lead to take ownership of the end-to-end delivery of the Digital Core into a designated US based manufacturing process area. You will work from an established deployment playbook, while also being expected to improve it. The role will focus on deploying a validated digital template into a new manufacturing environment and driving it through to go live. This is a highly autonomous US based role, reporting remotely into the Global Digital Core Deployment Lead. You will carry both deployment leadership and program management responsibility for your assigned process area. This includes owning the integrated plan, coordinating global template teams, managing site readiness, and supporting the go- or no-go decision process. This is not a template build role. It is a deployment role. The focus is making the template work in a real manufacturing environment, on a live CapEx timeline, within a GMP regulated setting.


Key Responsibilities-


  • Deployment Ownership
  • Own the end-to-end Digital Core deployment for the assigned process area, from template acceptance through to commissioning and go live.
  • Maintain and manage the site level Integrated Master Schedule, aligned to the CapEx project timeline and global template readiness roadmap.
  • Drive go live readiness reviews and support the formal go- or no-go decision process at each major deployment gate. Template Coordination and Release Acceptance
  • Coordinate with global Digital Core template teams to pull validated templates on schedule through the formal release acceptance process.
  • Track the Template Readiness Roadmap published by global teams and hold workstream leads accountable to committed release milestones.
  • Execute site acceptance testing and sign off the template release package for the assigned process area. Site Readiness.
  • Manage site readiness across infrastructure, configuration, master data, integration testing, and deployment preparation.
  • Cover both IT systems, including ERP, MES, LIMS and EAMS, and OT or shop floor systems, including DeltaV, Plant Bus and Ignition.
  • Act as the primary point of contact between the global program and the local site teams across operations, quality, engineering and CapEx delivery.
  • Ensure deployment activities are executed in line with GMP expectations and Computer Software Assurance principles. Program Management
  • Identify, track and escalate risks, dependencies and resource conflicts through the program  governance structure.
  • Maintain the RAID log, RAG dashboard and decision log.
  • Provide clear and timely reporting to the Global Deployment Lead and program PMO.
  • Run the local coordination rhythm across site level workstream leads, ensuring the deployment plan remains current, and dependency conflicts are visible. Playbook Contribution
  • Contribute lessons learned from the assigned process area to improve the deployment playbook.
  • Help make future deployments faster, clearer and more predictable.
  • Document site specific configuration decisions, integration outcomes and validation approaches as reusable assets for future deployment leads.

Experience Required-


  • 10 plus years of experience leading digital system deployments in regulated pharmaceutical, biotech or biologics manufacturing environments.
  • Proven experience owning end to end delivery from planning, site readiness, testing, validation, cutover and go live.
  • Strong exposure to integrated digital manufacturing environments, including ERP, MES, LIMS, EAM or adjacent platforms.
  • Working knowledge of OT and shop floor systems, ideally including DeltaV, Ignition, Plant Bus or automation integration points.
  • Strong understanding of GMP, GAMP 5, CSV and Computer Software Assurance expectations.
  • Experience operating in a CapEx, greenfield, brownfield expansion or new manufacturing process area environment.
  • Strong program management discipline, including IMS ownership, RAID, RAG, governance cadence, dependency management and go live readiness.
  • Ability to manage senior stakeholders across IT, automation, engineering, quality, operations and global template teams.
  • Comfortable holding global and local teams accountable to delivery milestones without direct line authority.
  • Ability to work autonomously under remote leadership, with a structured and proactive approach to issue resolution.
  • Experience in template-based deployments, first of kind deployments or new process area deployments would be a strong advantage.
  • Success Profile The right person for this role is a seasoned deployment practitioner who has delivered complex digital systems in regulated manufacturing environments before. They will be credible with both IT and engineering teams, rigorous in planning, and confident operating without daily oversight. They will understand how to manage the tension between global template expectations, local site realities, validation requirements and CapEx timelines. They will treat the deployment playbook as a living tool. They will follow it where it works, improve it where it does not, and leave the deployment better documented and easier to repeat. Above all, this person must be self-sufficient. They will not wait to be told what to do next. They will look at the timeline, identify what is at risk, escalate early, and drive the program forward. 

Skills Required

  • 10+ years leading digital system deployments in regulated pharmaceutical, biotech or biologics manufacturing environments
  • Proven experience owning end-to-end delivery from planning, site readiness, testing, validation, cutover and go live
  • Strong exposure to integrated digital manufacturing environments including ERP, MES, LIMS and EAM/EAMS
  • Working knowledge of OT and shop floor systems and automation integration points
  • Familiarity with DeltaV, Ignition and Plant Bus (preferred examples of OT/shop-floor systems)
  • Strong understanding of GMP, GAMP 5, Computer System Validation (CSV) and Computer Software Assurance principles
  • Experience operating in CapEx projects, greenfield/brownfield expansions or new manufacturing process area deployments
  • Strong program management discipline: IMS ownership, RAID logs, RAG dashboards, governance cadence and dependency management
  • Ability to manage senior stakeholders across IT, automation, engineering, quality, operations and global template teams
  • Ability to work autonomously under remote leadership with proactive issue resolution
  • Experience in template-based deployments or first-of-kind/new process area deployments
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The Company
Saratoga Springs, NY
200 Employees
Year Founded: 1981

What We Do

cb20 provides IT and AV solutions, delivering end-to-end consulting, implementation and managed services to a variety of hardware and software brands.

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