Maintenance Reliability Engineer

Working within a state-of-the-art aseptic drug product facility, the Maintenance Reliability Engineer is responsible for enhancing the reliability, availability, and maintainability of plant equipment and utilities. This role focuses on developing a robust reliability framework to minimize unplanned downtime and optimize asset lifecycle performance in a highly regulated cGxP environment.

Key Responsibilities

• Operational Support: Support complex manufacturing processes including Formulation, Vial/Syringe Filling, and Lyophilization.
• Strategy & Roadmapping: Design and execute a multi-year reliability roadmap, integrating condition monitoring and predictive maintenance.
• Data Analysis: Utilize business analytics (MTBF, MTTR, failure trends) to identify chronic issues and implement sustainable technical improvements.
• Maintenance Execution: Collaborate with cross-functional teams to refine job plans, ensuring tasks are risk-based, technically sound, and "right-first-time."
• Shutdown Management: Oversee reliability-critical work during shutdowns and non-commercial time to ensure seamless execution.
• Continuous Improvement: Lead root cause analysis (RCA) and FMEA activities to embed best practices and standard work into the site's culture.

Qualifications & Experience

• Education: Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or Software).
• Experience: * Minimum 5 years in a cGxP manufacturing maintenance or engineering role.
• Strong background in pharmaceutical or biotech environments (Aseptic fill/finish experience preferred).
• Technical Knowledge: * Proficiency in asset reliability methodologies (RCA, FMEA, PM Optimization).
• Experience with CMMS/EAM systems (e.g., Maximo).
• Familiarity with Lean, Six Sigma, or TPM methodologies.

Core Competencies

• Analytical Problem-Solving: Ability to translate complex data into actionable maintenance strategies.
• Influence: Proven ability to work across functional boundaries and drive results without direct authority.
• Communication: Strong technical writing skills for SOPs, specifications, and engineering documentation.