Maintenance Program Lead

Role: Maintenance Program Lead

Location: Indianapolis, Indiana

Industry : Biopharmaceuticals

Overview

Our client, a global pharmaceutical manufacturer, is seeking a Maintenance Program Lead to support a major capital program Indiana.

This role will be responsible for developing and implementing maintenance programs that ensure GMP manufacturing assets are operationally ready, compliant, and sustainable throughout their lifecycle. Working across Engineering, CQV, Operations, Reliability, and Maintenance functions, the Maintenance Program Lead will support the transition of systems and equipment from project delivery and startup into routine operations.

This is an excellent opportunity for professionals with experience in pharmaceutical startup projects, commissioning and qualification, maintenance strategy, operational readiness, reliability engineering, or asset management.

Key Responsibilities:

• Develop maintenance programs for GMP manufacturing equipment, process systems, utilities, and facility assets.
• Perform equipment criticality assessments and maintenance evaluations.
• Establish preventive maintenance (PM) strategies based on equipment risk, operational requirements, and manufacturer recommendations.
• Develop maintenance job plans, task lists, maintenance frequencies, and supporting documentation.
• Support continuous improvement of maintenance and reliability programs.

Calibration

• Develop calibration strategies and routines for GMP-critical instrumentation and equipment.
• Support instrument criticality assessments and calibration interval development.
• Ensure maintenance and calibration programs align with site quality standards and regulatory requirements.
• Collaborate with Engineering and Operations teams to ensure equipment maintainability and reliability.

CMMS Strategy

• Develop and maintain asset hierarchies within the site's CMMS platform.
• Support asset master data creation, validation, and bulk loading activities.
• Create and maintain maintenance plans, equipment records, task lists, and associated documentation.
• Ensure maintenance data integrity and compliance within SAP PM, Maximo, Blue Mountain, or similar systems.

Start up / Ops Readiness

• Partner with Engineering and CQV teams during commissioning, qualification, and startup activities.
• Support system turnover and handover from project teams to site operations and maintenance.
• Participate in equipment walkdowns, punch list resolution, and operational readiness reviews.
• Ensure maintenance requirements are integrated into startup planning and execution activities.

Compliance / Documentation

• Develop and maintain GMP-compliant maintenance documentation.
• Ensure maintenance programs comply with site procedures, quality systems, and regulatory expectations.
• Support internal audits, inspections, and regulatory readiness initiatives.
• Maintain accurate and controlled records in accordance with GMP requirements.

Experience:

Required

• Bachelor's Degree in Engineering, Technical Discipline, or equivalent industry experience.
• Experience within pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
• Experience supporting maintenance programs, commissioning and qualification activities, operational readiness, startup projects, reliability engineering, or asset management initiatives.
• Strong understanding of GMP manufacturing environments and regulatory requirements.
• Experience working with CMMS platforms such as SAP PM, Maximo, Blue Mountain, Infor EAM, or similar systems.

Preferred

• Experience supporting large capital projects, facility expansions, or greenfield manufacturing sites.
• Experience developing preventive maintenance programs and maintenance strategies.
• Experience with calibration programs and instrumentation systems.
• Knowledge of GMP utilities, process equipment, clean utilities, HVAC, and manufacturing systems.
• Familiarity with equipment criticality assessments, FAT/SAT activities, commissioning, qualification, and system turnover processes.