Maintenance Engineer (6 Month Contract)

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.

• 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.

• 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.