Reliability Engineer-Talent Bank

The Reliability Engineer will be responsible for improving the reliability, maintainability, and performance of manufacturing and utility systems in a GMP-regulated environment.

This role focuses on identifying and mitigating risk to ensure equipment uptime, regulatory compliance, and efficient asset lifecycle management.

The Reliability Engineer will lead root cause analyses, predictive maintenance strategies, and continuous improvement initiatives.

Key Responsibilities : Develop, implement, and manage a plant-wide asset reliability program aligned with GMP and FDA regulatory standards.

Conduct Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEA), and other risk-based methodologies to reduce equipment downtime and recurrence of failures.

Lead Reliability Centered Maintenance (RCM) initiatives and optimize preventive and predictive maintenance programs (PdM / CMMS).

Collaborate with Maintenance, Engineering, Operations, and Quality teams to ensure equipment performance meets production and compliance requirements.

Monitor key performance indicators (KPIs) such as MTBF (Mean Time Between Failures), MTTR (Mean Time to Repair), and OEE (Overall Equipment Effectiveness).

Oversee the development of reliability-related documentation (SOPs, maintenance plans, risk assessments) in compliance with GMP regulations.

Support capital projects by providing reliability and maintainability input into equipment design and commissioning (including FAT / SAT / IQ / OQ protocols).

Manage spare parts strategy and critical equipment lists to support business continuity.

Ensure compliance with EHS standards during equipment evaluation and modification.

Qualifications : Education & Experience : Bachelor’s Degree in Engineering (Mechanical, Electrical, Industrial or related field).

• 3+ years of experience in a GMP manufacturing environment, preferably in pharmaceuticals, biotechnology, or medical devices.

Proven experience in reliability engineering, maintenance optimization, and asset performance management.

Certifications (preferred) : Certified Reliability Engineer (CRL), CMRP, or equivalent.

Familiarity with Six Sigma, Lean Manufacturing, or TPM methodologies.

Skills : Strong knowledge of GMP, FDA regulations, and validation protocols.

Proficiency with CMMS (e.g., Maximo, SAP PM) and data analysis tools (Excel, Power BI, etc.).

Excellent problem-solving, communication, and cross-functional collaboration skills.

Ability to manage multiple priorities and drive long-term improvements.

Working Conditions : On-site work in a regulated manufacturing environment with occasional exposure to cleanrooms, utilities, and mechanical systems.

May require occasional off-hours support or response to critical equipment issues.

Drug Free Workplace Policy : In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment." Share Tech Group is committed to being an equal opportunity employer, fostering a diverse and inclusive workplace where all individuals are treated with respect and provided with equal opportunities for employment and advancement.

Powered by JazzHR