Position Overview The Engineering Manager is responsible for leading, developing, and coordinating a multidisciplinary engineering team to ensure the safe, compliant, and efficient delivery of engineering projects and maintenance activities in a regulated environment. This role requires a deep understanding of regulatory standards, quality systems, and engineering best practices to maintain product integrity, operational reliability, and regulatory compliance. Key Responsibilities Leadership & Team Management Lead and mentor a team of engineers, technicians, and support staff, fostering a culture of technical excellence, safety, and continuous improvement. Set performance objectives, conduct appraisals, and ensure professional development of team members. Allocate resources effectively across projects to meet business objectives and compliance requirements. Engineering Operations Oversee the design, implementation, and maintenance of equipment, systems, and facilities in accordance with engineering and regulatory standards (e.g., GMP, ISO 13485, AS9100, IEC, or equivalent). Manage capital projects from concept through commissioning, ensuring scope, cost, and schedule alignment. Ensure robust maintenance and calibration programs are in place to guarantee equipment reliability and data integrity. Regulatory Compliance & Quality Ensure engineering activities comply with applicable regulations, quality management systems (QMS), and internal policies. Prepare and review technical documentation (URS, design specifications, validation protocols, change controls). Support audits and inspections by regulatory bodies and customers. Lead risk assessments (FMEA, HAZOP, etc.) and implement mitigation strategies. Strategic & Continuous Improvement Contribute to strategic planning, budgeting, and resource forecasting. Drive innovation and process optimization initiatives to improve efficiency, sustainability, and product quality. Collaborate cross-functionally with Quality, Manufacturing, R&D, and EHS teams. Qualifications & Experience Essential: Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or related discipline). Minimum 8-10 years of experience in engineering roles, with at least 3 years in a leadership or management capacity. Previous experince in API manufacturing is essential