About the role

AI summarised

The Senior Reliability Engineer (Mechanical) is responsible for maintaining site-wide equipment and facilities within a pharmaceutical manufacturing environment. The role focuses on implementing predictive and preventive maintenance programs, conducting root cause failure analysis, and ensuring strict compliance with cGMP and EHS standards to maximize equipment uptime and reliability.

BiopharmaOnsite

Key Responsibilities

Maintain site-wide equipment and facilities, establishing optimization initiatives to enhance equipment reliability in compliance with cGMP, EHS, and Data Integrity requirements.
Execute reliability programs for plant Mechanical equipment by establishing proactive, predictive, and preventive maintenance programs.
Perform maintenance and inspection activities on plant equipment according to procedures, good engineering practices, and cGMP.
Lead and implement predictive maintenance programs, collect data, analyze results, and recommend corrective actions to reduce equipment failures.
Conduct root cause failure analysis (RCFA) to improve product quality and equipment reliability.
Establish equipment reliability standards by studying drawings, data sheets, and design specifications and verifying with OEMs.
Utilize EAMS (computerized maintenance management system) to analyze data and trends for decision-making and PM planning.
Support project design, construction, and commissioning through active involvement in testing and equipment modifications.
Develop and support TPM-OPC checklists, training and guiding operation teams in first-line maintenance tasks.
Improve mechanical system performance by conducting design feasibility studies and implementing methods to reduce downtime and optimize resources.

Requirements

Minimum 6 years of experience for Degree or 15 years for Diploma in Mechanical or Chemical Engineering.
Relevant experiences in pharmaceuticals, chemicals, or petrochemical industries.
Experience with Root Cause Failure Analysis, Equipment Criticality Ranking, PM/PdM optimization, and/or Failure Modes and Effects Analysis.
Strong knowledge and understanding of Current Good Manufacturing Practices (cGMP/GxP).
Familiar with government code of practice, regulations, Good Documentation Practice (GDP), and Data Integrity (DI).
Good Mechanical Maintenance Troubleshooting, Repairs, and Analysis Skills.
Ability to manage complex issues and foster consensus among cross-functional teams.
Working knowledge of MS Excel.
Demonstrated problem-solving and relationship management skills.
Experience in the pharmaceutical sector is preferred.
Proficiency in technical writing and document reviews is preferred.
Knowledge of contemporary technologies and best aseptic practices is preferred.
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving.