GxP Alarm Management Lead — Strategy & Validation

Investigo

Indianapolis (IN)

On-site

USD 140,000 - 190,000

Full time

11 days ago

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Job summary

Investigo is seeking an Alarm Management Program Lead on a contract basis for a pharmaceutical manufacturing facility in the United States. You will drive the execution, governance, and delivery tracking of a comprehensive alarm management program across multiple manufacturing nodes.

Starting mid-August 2026 for roughly 16.5 months, you will lead alarm rationalization, configuration, testing, validation, go-live readiness, SOP development, and on-site handoffs, collaborating with Automation

Qualifications

Lead alarm management programs or major alarm lifecycle workstreams in GxP environments.
Strong knowledge of ISA-18.2/IEC 62682 lifecycle principles and alarm governance.
Hands-on familiarity with PCS alarm configuration, HMI alarms, and escalation.
Experience leading cross-functional rationalization workshops.
Experience with historian reporting, KPIs, and archival verification.
Regulated environment validation and testing expertise.

Responsibilities

Establish and maintain alarm strategy and governance across functions.
Lead alarm rationalization, classification, prioritization, and documentation.
Coordinate PCS alarm configuration implementation and peer review.
Drive alarm notification, PI Historian integration, dashboards, and KPI reporting.
Plan validation/testing activities and go-live readiness.
Support SOP development, alarm training, and operations handoff.
Maintain ongoing monitoring cadence (daily/weekly/monthly).