Job Title: CMMS Specialist

Job Description

The CMMS Specialist/Associate will support the implementation, maintenance, and optimization of Enterprise Asset Management (EAM) systems within a GMP-regulated pharmaceutical environment. This role focuses on ensuring accurate asset data, managing controlled documents, and supporting compliance with internal procedures and regulatory requirements. The ideal candidate will have experience with computerized maintenance management systems (CMMS), document control practices, and working in a highly regulated industry such as pharmaceuticals or biotechnology.

Responsibilities

• Maintain and update asset records, preventive maintenance schedules, and work order data in the EAM system.
• Ensure data integrity and compliance with GMP standards.
• Collaborate with engineering, maintenance, and quality teams to support asset lifecycle management.
• Manage controlled documents related to equipment, maintenance procedures, and calibration records.
• Ensure proper version control, archival, and retrieval of documents in accordance with SOPs and regulatory requirements.
• Support audits and inspections by providing accurate and timely documentation.
• Assist in the development and revision of SOPs related to CMMS and document control processes.
• Ensure alignment with company quality systems and regulatory expectations (FDA, EMA, etc.).
• Participate in deviation investigations and CAPA implementation related to asset and document management.
• Provide training and guidance to system users on CMMS functionality and document control procedures.
• Act as a liaison between system users and IT/technical support teams.

Essential Skills

• 1+ years of experience with CMS/EAM systems in a GMP-regulated environment.
• Experience with EAMs, preferably in large companies.
• Strong understanding of asset management principles and regulatory compliance.
• Excellent attention to detail, organizational skills, and ability to work cross-functionally.
• Proficiency in Microsoft Office Suite and data analysis tools such as Power BI.

Additional Skills & Qualifications

• High School Diploma, Associates or Bachelor’s degree in Engineering, Life Sciences, Information Systems, or related field with relevant experience.

Work Environment

The role is based in a pharmaceutical manufacturing facility with office space within the engineering compliance team. Standard working hours are Monday to Friday, from 8 AM to 5 PM. Once trained, there may be some flexibility in working hours at the manager's discretion.