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About the Role

Lead the end-to-end delivery of the Digital Core into a US-based manufacturing process area for a biopharma organization. This autonomous role involves deploying a validated digital template, improving the deployment playbook, and driving the process to go-live within a GMP regulated setting. Responsibilities include deployment leadership and program management, owning the integrated plan, coordinating global template teams, managing site readiness, and supporting go/no-go decisions.

Responsibilities

Own end-to-end Digital Core deployment from template acceptance to commissioning and go-live.
Maintain and manage the site-level Integrated Master Schedule, aligned with CapEx project timelines and global template readiness.
Drive go-live readiness reviews and support formal go/no-go decisions at major deployment gates.
Coordinate with global Digital Core template teams for validated template release acceptance.
Track the Template Readiness Roadmap and ensure workstream leads meet committed release milestones.
Execute site acceptance testing and sign off template release packages.
Manage site readiness across infrastructure, configuration, master data, integration testing, and deployment preparation.
Cover IT systems (ERP, MES, LIMS, EAMS) and OT/shop floor systems (DeltaV, Plant Bus, Ignition).
Act as the primary contact between the global program and local site teams (operations, quality, engineering, CapEx).
Ensure deployment activities align with GMP expectations and Computer Software Assurance principles.
Identify, track, and escalate risks, dependencies, and resource conflicts through program governance.
Maintain the RAID log, RAG dashboard, and decision log.
Provide clear and timely reporting to the Global Deployment Lead and program PMO.
Run local coordination with site-level workstream leads to keep the deployment plan current and identify dependency conflicts.
Contribute lessons learned to improve the deployment playbook.
Document site-specific configuration decisions, integration outcomes, and validation approaches as reusable assets.

Requirements

10+ years leading digital system deployments in regulated pharmaceutical, biotech, or biologics manufacturing environments.
Proven experience owning end-to-end delivery: planning, site readiness, testing, validation, cutover, and go-live.
Strong exposure to integrated digital manufacturing environments (ERP, MES, LIMS, EAM, or adjacent platforms).
Working knowledge of OT and shop floor systems (DeltaV, Ignition, Plant Bus, or automation integration points).
Strong understanding of GMP, GAMP 5, CSV, and Computer Software Assurance expectations.
Experience operating in CapEx, greenfield, brownfield expansion, or new manufacturing process area environments.
Strong program management discipline (IMS ownership, RAID, RAG, governance cadence, dependency management, 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, first-of-kind, or new process area deployments is a strong advantage.

Skills

Digital system deployment
Program management
Stakeholder management
Autonomous work
Structured problem-solving
Proactive issue resolution
Planning rigor
Credibility with IT and engineering teams
Managing global template expectations vs. local site realities
Validation requirements management
CapEx timeline management
Self-sufficiency
Risk identification
Early escalation
Driving program forward

Location

US based
Remote

Work Type

Autonomous
Remote

Experience Level

10+ years of experience

About the Company

cb20 is an award-winning provider of managed IT and audio-visual services.
Serves organizations across New York, Massachusetts, and the greater New England region.
Over 30 years of experience with world-class engineers and trusted partnerships.
Delivers confidence, security, and "An Experience Above".
Won Albany Business Review Best Places to Work and Albany Times Union Top Places to Work five years in a row.
Achieved #1 spot in the over 100 category at the ABR Best Places to Work event in 2025.
Values people as its greatest asset.