Operations Engineer

Key Responsibilities

• Support plant operations in the end to end manufacture (inclusive of changeover) of Active Pharmaceutical Ingredients (APIs) in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs)
• Collaborate cross-functionally to ensure safety, quality, and operational investigations are thoroughly conducted and reported in a timely manner
• Contribute to continuous improvement initiatives, including IMEX activities and the development, implementation, and periodic review of documentation that enhances operational effectiveness and regulatory compliance
• Maintain a state of perpetual safety and GMP compliance on the shop floor, ensuring audit-readiness at all times
• Execute production, pre-maintenance, and post-maintenance intervention activities to meet manufacturing targets and reduce equipment downtime
• Ensure that pre-manufacturing checks are performed safely, compliantly in order to meet manufacturing plan
• Review operational tasks in alignment with Manufacturing Standard Work (MSW) and Operation Standard Work (OSW) to optimize workflow efficiency
• Lead/participate in troubleshooting activities for processing issues and deviations, collaborating cross-functionally to drive immediate and preventive actions to meet manufacturing targets and reduce equipment downtime
• Lead/contribute to EHS and quality investigations, generate reports, and drive resolution of issues identified during operations, batch record review, cleaning instructions review and associated manufacturing documentation
• Drive Continuous Improvement (CI) initiatives using the Plan-Do-Check-Act (PDCA) methodology to enhance safety, quality, and productivity
• Lead/support the development of risk assessments and job safety assessments (JSAs); participate in HAZOP reviews as needed
• Author and review Standard Operating Procedures (SOPs); ensure SOPs remain current and compliant