Associate Director

3 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.https://www.bioconbiologics.comEducation Qualification: Bachelor’s or Master’s degree in Mechanical .Experience: 20+ years of experience in maintenance leadership within biopharma or regulated industries.Roles and Responsibilities1. 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 inspections2. 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 contracts3. 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 excellence4. 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 maintenance5. 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 operations6. Qualifications & SkillsBachelor’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 operationsStrong 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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