Associate Director

5 days ago

Bangalore, India Biocon Biologics Full time

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives. Education Qualification: Bachelor’s or Master’s degree in Mechanical . Experience: 20+ years of experience in maintenance leadership within biopharma or regulated industries. Roles and Responsibilities 1. Strategic Leadership -Develop and implement maintenance strategies aligned with business goals and global standards -Lead cross-functional shutdown planning and execution, including coordination of asset investment programs -Represent the maintenance function in steering committees and regulatory inspections 2. Operational Oversight -Oversee daily maintenance activities for production equipment, utilities, HVAC, cleanrooms, and support systems -Ensure preventive and predictive maintenance programs are executed effectively to minimize downtime and extend equipment life -Manage CMMS systems, work orders, spare parts inventory, and vendor contracts 3. Team Management -Supervise and develop maintenance teams across multiple facilities (e.g., B1–B5, W20) -Conduct training and competency development for technicians and engineers -Drive a culture of safety, compliance, and performance excellence 4. Regulatory & Compliance -Ensure adherence to cGMP, US FDA, EU-GMP, and other global regulatory standards -Lead audit readiness and support inspections by regulatory bodies -Maintain documentation and SOPs for equipment qualification, calibration, and maintenance 5. Continuous Improvement -Apply reliability-centered maintenance, lean, and Six Sigma methodologies to improve asset performance -Analyze maintenance KPIs and implement corrective actions for recurring issues -Drive sustainability initiatives and energy optimization in maintenance operations 6. Qualifications & Skills Bachelor’s or Master’s degree in Mechanical . 20+ years of experience in maintenance leadership within biopharma or regulated industries. Expertise in HVAC, utilities, automation systems (e.g., DeltaV, ABB 800xA), and cleanroom operations Strong knowledge of CMMS, GAMP 5, ISA-88, and regulatory compliance. Proven ability to lead cross-functional teams and manage large-scale projects.

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