Associate, Mechanical Equipment Engineering

(Duties listed in order of greatest importance. Other responsibilities may be assigned.)

• Owns and drives equipment lifecycle management activities including URS development design review FAT/SAT commissioning qualification operational improvement and end-of-life planning.

• Leads reliability engineering initiatives including FMEA RCA MTBF/MTTR analysis RCM strategies and predictive/ preventive maintenance optimization.

• Ensures preventive and corrective maintenance activities are executed safely timely and meet quality/cGMP requirements. Ensures downtime data accuracy and uses analytics to identify chronic issues and reliability improvement opportunities.

• Performs engineering evaluations of equipment failures defines improvement actions and implements permanent solutions to enhance equipment availability compliance and operational performance.

• Leads and coordinates equipment improvement projects modification wor and asset upgrade initiatives to improve capability capacity and system robustness.

• Maintains technical documentation equipment master data criticality assessments obsolescence reviews and lifecycle records in compliance with cGMP SOPs and audit requirements.

• Develops long-term asset replacement strategy and capital planning based on condition assessments failure data and lifecycle evaluation.

• Provides leadership to promote teamwork open communication and technical development for technicians and cross-functional teams. May lead multifunction project teams or major shutdown planning.
• Provides technical input and analysis to support site-level strategic planning related to equipment reliability asset lifecycle and performance optimization

• Reviews monthly spending cost forecasts and ensures responsible budget management for assigned equipment systems.

Site Specific Essential Responsibilities

Essential Functions

• Supports equipment qualification validation change controls and regulatory compliance requirements.
• Collaborates closely with Production Maintenance Engineering Quality and EHS to ensure equipment reliability and safe operation.
• Supports improvement frameworks such as TPM Lean Six Sigma and digitalization initiatives.

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