Specialist - Facility & Operations

You will be responsible for implementing and executing the operating guidelines for the cleanroom facility and managing technical operations by anticipating demand and arranging the supply of all cleanroom requirements. Your role will involve acting as a Single Point of Contact (SPOC) for all operational activities related to labs and activities, ensuring the smooth functioning of all labs, improving existing systems and processes, and maintaining operational standards. Key Responsibilities: - Managing day-to-day site operations for all the labs - Supervising and directing on-site instrument and equipment Calibration and qualification - Generating and reviewing GMP documentation such as Standard Operating Procedures, non-conformance reports, deviations, CAPA, cleaning records, and temperature monitoring - Verifying all annexures generated by lab technicians like cleaning records and temperature monitoring - Liaising between internal stakeholders and vendors for calibration, AMC, breakdown, and maintenance of instruments - Working with Quality & Compliance to ensure all-time Audit readiness from a Lab & MFG perspective - Improving operational management systems, processes, and best practices - Creating PR for all instrument AMC and utility vendors - Coordinating with utility vendors for the timely delivery of materials like liquid nitrogen and gas cylinders - Recording and disposing of Biomedical waste - Performing routine stock checks to maintain levels of critical stock consumables and restock gowning garments - Supervising lab technicians in their day-to-day activities - Providing training and mentoring to ensure a good understanding of tasks allocated to lab technicians - Driving R&D Lab & Equipment procurement, maintenance & management - Supporting R&D sample management and acting as a SPOC for clinical samples received for R&D purposes - Supporting R&D procurement activities to consolidate orders for cost savings Competencies Required: - Understanding of IQ/OQ/PQ for instruments and associated documentation - Knowledge of GMP documentation and cleanroom practices - Experience with operations in the ERP system (SAP) and material inspection Soft Skills: - Proficiency in basic IT skills and MS Office (Excel, Word) - Good communication skills - Team player, collaborative, resourceful, and committed to quality - Detail-oriented and strategic thinker - Enthusiastic and committed Qualifications: - Minimum Bachelor's degree in Science - Eight+ years of related experience in relevant areas of lab operation and cleanroom area in pharmaceuticals - Prior experience working with GMP systems Working Conditions: - Role Type: Full Time and Onsite - Work Hours: General Shift (9:00 AM to 6:00 PM) and Post-Noon Shift (2:00 PM to 11:00 PM on a rotational basis) with two days off each week - Travel Requirements: Occasional, as required for business needs - Base Location: Immuneel Therapeutics Private Limited, Bangalore,