Job Description:Qualification: Bachelor’s degree in mechanical engineering
Experience (in years): Minimum 10-15 years’ experience in formulation plant (Preferably OSD Plant)
Exposure/ Knowledge On: Operation and maintenance of OSD equipment’s like RMG, HSMG, FBP, FBC, FBD, FBE, Compression machines, Coating machine, Blenders, Blisters pack machine, Sachet filling machine, Cartonator, Sifter, Multi-mill, Quadro mills, OG mills, RLAF and lyophilizer, carbonators, sachet filling machine. Budgeting, Energy Efficient system Exposure to black utilities like chiller, boiler etc. Vendor Management, Regulatory Audit exposure, Statutory requirements.
Technical Skills: Qualification, Validation, Operation and Maintenance activities related to process equipment’s & Utilities. Trouble shooting, Vendor management, Spares & Consumables Management, Equipment life cycle management, Energy savings.
GMP, GDP, QMS (Change control, Deviation, CAPA management).
Roles & Responsibilities: (Tasks)- Responsible for management of process mechanical equipment’s and auxiliary equipment’s to ensure continuous availability of production run time in plants as per specifications.
- Good knowledge of maintenance of OSD Process equipment like Extruders, Tablet Compression, RMG, FBE, FBD, FBC, FBE Coating machine, blenders, Blisters pack machine, ASRS, sachet filling machine, cartonator, Lyophilizer, stick/sachet packing machine.
- Adherence to Standard Operating Procedures, Safety, cGMP, GDP, GEP and EHS requirements.
- Extensive experience in the installation and commissioning of new equipment in plant settings, including documentation processes such as developing and verifying User Requirements Specifications (URS), conducting Design Qualifications (DQ), overseeing Factory Acceptance Tests (FAT), and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure compliance with all operational and regulatory standards.
- Lead and oversee modifications of existing equipment and machinery to enhance performance, efficiency, and reliability.
- Responsibility for overall maintenance related activity and to track the preventive maintenance activity as per the schedule.
- Identify opportunities for improvement, design and implement upgrades, and ensure minimal disruption to ongoing operations.
- Collaborate with cross-functional teams to drive continuous improvement initiatives to optimize equipment performance and extend the operational life of process equipment’s.
- Perform comprehensive risk management and risk analysis to identify potential challenges in equipment and process performance and develop strategies to mitigate identified risks, ensuring operational safety and efficiency.
- To ensure all time readiness for external and internal audits
- To design and implement preventive maintenance programs based on MTTR and MTBF data to minimize equipment downtime and extend the lifespan of machinery.
- To conduct reliability analysis, including Failure Modes and Effects Analysis (FMEA), Root Cause Analysis (RCA), and reliability modelling.
- To oversee the management of spare parts inventory to ensure timely availability and maintain optimal stock of critical spares having long delivery time.
- Track and analyze key performance indicators (KPIs) related to process maintenance, such as equipment reliability, downtime, and maintenance costs.
- Implementation and training of Engineering personnel in cGMP and safety.
- To develop and train engineering personnels.
- Development of SOP s, Change Control Management, Deviation Handling and CAPAs., Root Cause Analysis Failure Investigation etc.
- Preparation of annual budget and adjust the budget periodically based on changes in operational needs and ensure expenses are within the budget.
- To develop and implement energy conservation strategies to reduce energy consumption and operational costs.
- Effective co-ordination with QA, Manufacturing and purchase team.
- To participate in project work related to commissioning, qualification, upgradation of system and equipment’s.
- To co-ordinate with maintenance service providers and vendors. Evaluate vendor performance, negotiate service agreements and ensure the timely delivery of parts and services.
- To implement cost control measures for spare parts management, including budget adherence and cost reduction strategies. Evaluate and optimize procurement processes to achieve cost savings
- Facing Internal and Regulatory audits.
- Supervise and manage a team of executives and technician and assign and delegate tasks to team members, ensuring clear communication of roles and responsibilities.
Monitor task completion and provide feedback and mange respective Appraisal cycle.
Additional/ Preferrable Skills: (Desirable Criteria):Water system, EMS, BMS system, HVAC, Air Compressor, cooling tower, Chiller, boiler and pure steam generator, calibration activities, computer system validation qualification.
Location:Ferring India Laboratories
