Specialist II, CMMS & Calibration

Job Responsibilities

Maximo System Administration & Master Data

• Administer the Maximo system as the site subject matter expert (SME), including all master data additions and changes.
• Create and maintain asset records in Maximo, ensuring data accuracy, consistency, and integrity across site users and processes.
• Identify and implement continuous improvements to Maximo data quality and workflows, determining and approving configuration and workflow changes within their area of responsibility and established site standards.

Calibration Planning, Tracking & Reporting

• Plan and schedule calibration of site instruments (e.g., temperature, pressure, and flow) in Maximo, determining calibration job plans and frequencies based on instrument criticality, usage, and performance history, in alignment with Quality and calibration program requirements, and ensuring completed calibrations are accurately recorded.
• Evaluate Out of Tolerance (OOT) events, vendor calibrations, and missing assets for site calibrations, determining required follow-up actions and when escalation is warranted.
• Compile and report site calibration KPIs, analyzing data trends to identify root causes and recommend and implement solutions or improvements.

Documentation, Change Control & Compliance

• Author, revise, and continuously improve SOPs and processes related to areas of responsibility.
• Apply change control to technical documentation across all areas, ensuring revision and storage practices meet cGMP requirements.

Training & Site Collaboration

• Maintain and deliver Maximo training materials and sessions for site users, determining program content and updates.
• Serve as a Maximo point of contact for site users, resolving system and process issues and determining when escalation to management is required.
• Present calibration and Maximo status, progress, and issues in team meetings.

Experience & Education

Minimum Qualifications

• Demonstrated experience administering IBM Maximo or a comparable CMMS/EAM system, including asset, location, job plan, and preventive maintenance/calibration record setup
• Experience with master data management, including data validation, bulk data loads and changes, and maintaining data integrity
• Working knowledge of calibration and/or maintenance planning and scheduling principles
• Prior experience in a cGMP or other regulated manufacturing environment, including change control and Good Documentation Practices (GDP)
• Ability to analyze data, identify trends, and present KPIs and findings clearly to stakeholders
• Strong organizational skills, with the ability to manage multiple priorities and exercise sound independent judgment with limited supervision
• Effective written and verbal communication skills, including the ability to train and support users with varying technical proficiency
• Proficiency with Microsoft Office, particularly Excel

Preferred Qualifications

• Bachelor’s degree in engineering, a technical discipline, or a related field, or an equivalent combination of education and experience
• 3+ years of experience with Maximo administration or CMMS master data management
• 2+ years of experience in calibration or maintenance planning within a pharmaceutical, biotechnology, or other regulated manufacturing environment
• Experience supporting a calibration program, including investigations and vendor calibration management
• Experience with reporting and analytics tools.
• Experience developing and delivering technical training

Physical & Work Environment

Work is performed in a combination of office, laboratory, and cGMP manufacturing environments.

Work Schedule

Monday–Friday, standard business hours, with flexibility to work additional hours as needed to meet business needs.