Team member - Drug Substance

Roles & Responsibilities

• Maintain manufacturing equipment to ensure correct functionality, calibration compliance, and operation within validated process parameters.
• Develop and guide the team toward achieving zero downtime, higher equipment reliability, and maximum availability through proactive maintenance strategies.
• Lead continuous improvement initiatives such as LDM, TPM, debottlenecking, and resource optimization, while leveraging cross-site learnings for enhanced productivity and cost efficiency.
• Prepare CAPEX proposals, conduct feasibility studies, secure approvals, and ensure timely execution of projects in compliance with regulatory and business requirements.
• Manage OPEX budgeting, tracking, and monitoring, along with developing and reviewing KPIs to drive operational efficiency and cost control.
• Conduct breakdown analysis, improve preventive maintenance, and collaborate with cross-functional teams to resolve discrepancies and implement corrective actions.
• Ensure compliance with GMP, safety standards, and SOPs, maintain audit readiness, and manage QMS elements including documentation, CAPA closure, and training.
• Build a high-performing team by setting goals, conducting performance reviews, coaching employees, recognizing contributions, and driving capability development for seamless process engineering transitions.
"

Function: Other
Experience Level: Mid-Senior Level