Alarm Management Program Lead

EXOS; Indianapolis (IN); On-site; USD 120,000 - 150,000; Full time

Job summary

EXOS is seeking a Foundry Alarm Management Program Lead to support a Medicines Foundry site in a GMP/GxP environment, guiding alarm lifecycle activities and program execution.

You will partner with Site Automation Engineering, global automation partners, operations, quality, process engineering, and safety stakeholders to drive readiness, workshops, and go-live deliverables, including validation and reporting.

Qualifications

• Leading alarm management programs or major alarm lifecycle workstreams in GxP manufacturing or process control environments.
• Strong knowledge of ISA 18.2 and IEC 62682 alarm lifecycle principles.
• Experience with alarm configuration concepts, HMI alarms, and governance of priority, limits, delays.

Responsibilities

• Lead the alarm management program across lifecycle phases and coordinate execution.
• Align program scope and readiness with Site Automation Engineering and stakeholders.
• Facilitate alarm rationalization workshops with cross-functional teams.
• Translate strategy into work packages, RACI, and status reporting.
• Maintain program plans, issue/risk logs, and deliverable progress reporting.
• Support validation, testing, and go-live readiness activities.

Skills

Alarm management leadership

GxP manufacturing experience

Stakeholder management

Tools

ISA 18.2

IEC 62682

Rockwell control systems

Smartsheet

Power BI

Historian data

Alarm management tools

Job description

The Foundry Alarm Management Program Lead will support a customer Medicine Foundry site by leading the alarm management program across key lifecycle phases within a GxP and GMP regulated pharmaceutical manufacturing environment. This role will work closely with Site Automation Engineering, global automation partners, operations, quality, process engineering, health, safety, environment, and process safety stakeholders to drive program execution, workshop alignment, readiness activities, and deliverable progress.

This role will maintain program plans, issue and risk logs, action trackers, decision records, and deliverable level status reporting. The Foundry Alarm Management Program Lead must be available for onsite collaboration as required by project activities, workshops, reviews, and go live readiness work.

Responsibilities:

• Lead the Foundry Alarm Management Program and coordinate program execution across alarm lifecycle phases.
• Partner with Site Automation Engineering and cross functional Foundry stakeholders to align program scope, priorities, deliverables, and readiness expectations.
• Facilitate alarm rationalization workshops with automation engineering, operations, process engineering, process translation and execution, quality, health safety environment, and process safety representatives.
• Translate program strategy into executable work packages, RACI models, workshop plans, deliverables, acceptance criteria, and status reporting.
• Maintain program plans, action trackers, issue logs, risk logs, decision records, and deliverable level progress reporting.
• Support alarm philosophy alignment, alarm rationalization, configuration management, alarm performance monitoring, and lifecycle governance.
• Coordinate historian reporting concepts for alarm data collection, dashboards, key performance indicators, standing alarms, nuisance alarms, flood analysis, and archival verification.
• Support validation and testing activities, including test plan development, critical alarm testing, integration testing, deviation tracking, rework tracking, and validation summary report support.
• Drive timely decision making, action closure, risk escalation, stakeholder alignment, and operational readiness for program milestones.
• Support creation of standard operating procedures, training materials, go live readiness packages, operational handoff plans, and continuous improvement routines as needed.

Tools and Technologies:

• Process Control Systems
• Alarm management lifecycle tools and methods
• ISA 18.2
• IEC 62682
• Historian reporting and alarm data collection
• Dashboard and key performance indicator reporting
• Rockwell control systems
• Smartsheet
• Power BI
• Alarm notification and escalation systems
• Validation and testing documentation

Qualifications:

Required Qualifications

• Demonstrated experience leading alarm management programs or major alarm lifecycle workstreams in GxP manufacturing or process control environments.
• Strong working knowledge of ISA 18.2 and IEC 62682 alarm management lifecycle principles, alarm philosophy, alarm rationalization, configuration management, and alarm performance monitoring.
• Practical familiarity with Process Control Systems alarm configuration concepts, Human Machine Interface alarm presentation, alarm help, priority assignment, limits, delays, and alarm shelving or suppression governance where applicable.
• Experience facilitating cross functional rationalization workshops with Site Automation Engineering, Global Automation Engineering, Operations, Process Engineering, Process Translation and Execution, Quality, Health Safety Environment, and Process Safety representatives.
• Experience with historian reporting concepts for alarm data collection, dashboards, key performance indicators, standing alarms, nuisance alarms, flood analysis, and archival verification.
• Strong validation and testing experience in a regulated environment, including test plan development, critical alarm testing, integration testing, deviation tracking, rework tracking, and validation summary report support.
• Ability to translate program strategy into executable work packages, RACI models, workshop plans, deliverables, acceptance criteria, and status reporting.
• Excellent communication and stakeholder management skills with the ability to drive decisions, close actions, and elevate risks in a timely manner.

Preferred Capabilities

• Pharmaceutical or life sciences manufacturing experience, preferably in a greenfield site, startup, commissioning, qualification, or operational readiness context.
• Experience with alarm notification and escalation systems, on call schedules, low occupancy alarm strategies, and integration testing of notification paths.
• Experience creating standard operating procedures, training materials, go live readiness packages, operational handoff plans, and continuous improvement routines.
• Familiarity with Smartsheet, Power BI, or similar tools for program tracking, key performance indicator visualization, risk and action management, and stakeholder communication.
• Familiarity with Rockwell and DeltaV control systems.