We are seeking a high-calibre Maintenance Engineer to lead a critical compliance and operational excellence initiative. In this role, you will design, optimize, and implement robust Preventive Maintenance (PM) and calibration programs from the ground up. Working cross-functionally with Quality, Validation, and Engineering, you will ensure our automated manufacturing systems and utilities are fully optimized, CMMS-integrated, and strictly compliant with FDA and ISO standards.
Key Responsibilities
- Program Development: Author and standardize compliant PM and calibration procedures for critical automated manufacturing equipment and utility instrumentation.
- CMMS Optimization: Enhance asset hierarchies, workflows, scheduling, and documentation controls within the site's CMMS (e.g., SAP PM).
- Compliance & Audit Readiness: Map maintenance processes against FDA/GMP regulations, identify data integrity gaps, and ensure the site is fully inspection-ready.
- Cross-Functional Collaboration: Partner with QA and Validation to support CAPAs, change controls, and equipment qualifications; train technical staff on new protocols.
Qualifications & Experience
- Education: Degree in Engineering, Automation, Mechatronics, or a related technical discipline.
- Experience: 5+ years in a strictly regulated environment (Medical Devices, Pharma, or Biotech).
- Technical Expertise: Proven track record of building asset reliability and calibration programs from scratch, paired with strong hands-on CMMS platform experience.
- Regulatory Knowledge: Deep understanding of FDA regulations, GMP requirements, and ideally ISO 13485 / 21 CFR Part 820.
- Skills: Exceptional technical writing, risk assessment capabilities, and stakeholder management skills.
Project Deliverables
By the conclusion of this initiative, you will have successfully delivered:
- Fully integrated, compliant PM and calibration frameworks within the CMMS.
- Closed compliance gaps and bulletproof documentation.
- A sustainable, audit-ready framework supporting long-term operational excellence.
