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Sushen Medicamentos

ORGANIZATIONAL DETAILSCompany: Sushen Medicamentos Pvt. Ltd. Department: Maintenance &amp; Engineering Location: Ahmedabad, Gujarat Reports To: Assistant Manager - Maintenance / Maintenance and Projects Head Position Type: Full-Time, Permanent Experience Level: 4-5 Years (Mandatory: EU GMP Approved Plant Experience)ABOUT SUSHEN MEDICAMENTOSSushen Medicamentos Pvt. Ltd. is a leading pharmaceutical services company with global operations, specializing in:<ul><li>Pharmaceutical Project Management Services (PMS): Comprehensive turnkey solutions for manufacturing infrastructure</li><li>Contract Development and Manufacturing Organization (CDMO): Specialized manufacturing services with expertise in effervescent tablets and solid dosage forms</li></ul>Operating under stringent regulatory standards including cGMP, WHO-GMP, USFDA, and EMA compliance, Sushen is committed to delivering pharmaceutical excellence globally.POSITION SUMMARYThe Maintenance Engineer - Solid Oral Dosage will be responsible for ensuring optimal performance, reliability, and regulatory compliance of all equipment and systems used in solid oral dosage (tablets, capsules, effervescent tablets) manufacturing operations. This role requires hands-on technical expertise in maintaining sophisticated pharmaceutical manufacturing equipment while adhering to EU GMP standards.The ideal candidate will have proven experience working in EU GMP approved pharmaceutical plants with a strong foundation in either electrical or mechanical engineering, applied specifically to solid dosage manufacturing environments.KEY RESPONSIBILITIESEquipment Maintenance &amp; Reliability<ul><li>Perform preventive and corrective maintenance on solid oral dosage manufacturing equipment including:</li><li>Tablet compression machines (rotary tablet presses, single/multi-station presses)</li><li>Capsule filling machines (automatic/semi-automatic)</li><li>Granulation equipment (high shear granulators, fluid bed processors)</li><li>Blenders and mixers (V-blenders, double cone blenders, bin blenders)</li><li>Coating machines (film coating pans, sugar coating equipment)</li><li>Milling and sieving equipment</li><li>Tablet dedusters and metal detectors</li><li>Effervescent tablet manufacturing equipment</li><li>Material handling systems (conveying, vacuum transfer)</li><li>Troubleshoot equipment breakdowns and implement rapid corrective actions to minimize production downtime</li><li>Monitor equipment performance parameters and identify potential failure points</li><li>Maintain equipment logs, maintenance records, and history cards as per GMP requirements</li><li>Coordinate with equipment vendors for specialized maintenance and technical support</li></ul>Electrical/Mechanical Systems ManagementFor Electricals :<ul><li>Maintain electrical control panels, motor control centers (MCCs), and variable frequency drives (VFDs)</li><li>Troubleshoot PLC-based control systems, HMI interfaces, and SCADA systems</li><li>Ensure proper functioning of interlocks, safety circuits, and emergency stop systems</li><li>Maintain power distribution systems, lighting, and electrical safety systems</li><li>Handle electrical calibration and instrumentation maintenance</li></ul>For Mechanicals :<ul><li>Maintain mechanical drive systems, gearboxes, bearings, and transmission components</li><li>Manage hydraulic and pneumatic systems including compressors, valves, and cylinders</li><li>Perform alignment, balancing, and vibration analysis of rotating equipment</li><li>Maintain cooling systems, lubrication systems, and material handling mechanisms</li><li>Handle mechanical modifications and upgrades to existing equipment</li></ul>EU GMP Compliance &amp; Documentation<ul><li>Execute all maintenance activities in strict compliance with EU GMP guidelines</li><li>Maintain comprehensive documentation including:</li><li>Preventive maintenance schedules and execution records</li><li>Breakdown reports and corrective action records</li><li>Equipment qualification documents (IQ/OQ/PQ)</li><li>Change control documentation</li><li>Deviation and CAPA records related to equipment</li><li>Standard Operating Procedures (SOPs) for maintenance activities</li><li>Support qualification and validation activities for new equipment installations</li><li>Participate in regulatory audits and inspections, providing technical documentation and explanations</li><li>Ensure maintenance activities do not compromise product quality or GMP compliance</li><li>Follow cleanroom protocols and hygiene requirements during maintenance in production areas</li></ul>Utilities &amp; Support Systems<ul><li>Support maintenance of critical utilities serving solid dosage manufacturing:</li><li>Compressed air systems (instrument air, plant air)</li><li>HVAC systems maintaining environmental conditions in production areas</li><li>Dust extraction systems (for tablet compression, coating, granulation areas)</li><li>Vacuum systems</li><li>Clean utilities (purified water systems as applicable)</li><li>Monitor utility parameters and ensure consistent supply to manufacturing operations</li><li>Coordinate with utilities team for planned shutdowns and emergency situations</li></ul>Continuous Improvement &amp; Technical Support<ul><li>Identify opportunities for equipment reliability improvement and efficiency enhancement</li><li>Participate in root cause analysis for recurring equipment failures</li><li>Contribute to CAPA (Corrective and Preventive Actions) related to equipment issues</li><li>Support technology transfer and scale-up activities for new products</li><li>Assist in preparation of technical specifications for new equipment procurement</li><li>Maintain spare parts inventory and coordinate timely procurement of critical components</li></ul>Safety &amp; Compliance<ul><li>Follow all electrical/mechanical safety standards and lockout-tagout (LOTO) procedures</li><li>Ensure compliance with industrial safety regulations and EHS requirements</li><li>Use appropriate Personal Protective Equipment (PPE) and ensure team compliance</li><li>Participate in safety training programs and incident investigations</li><li>Maintain housekeeping standards in maintenance workshops and work areas</li></ul>REQUIRED QUALIFICATIONSEducation<ul><li>Bachelor's degree in Electrical Engineering OR Bachelor's degree in Mechanical Engineering (B.E./B.Tech)</li></ul>Experience<ul><li>Total Experience: 4-5 years in maintenance engineering roles</li><li>Mandatory Requirement: Minimum 3 years of hands-on experience in EU GMP approved pharmaceutical manufacturing plants</li><li>Solid Dosage Experience: Proven experience maintaining solid oral dosage (tablets/capsules) manufacturing equipment</li><li>Pharmaceutical Industry: Strong understanding of pharmaceutical manufacturing environment and cGMP requirements</li></ul>Technical SkillsCore Technical Competencies:<ul><li>Strong troubleshooting and diagnostic skills for pharmaceutical manufacturing equipment</li><li>Hands-on experience with tablet compression, capsule filling, granulation, and coating equipment</li><li>Understanding of process flow in solid oral dosage manufacturing</li><li>Proficiency in reading and interpreting technical drawings, P&amp;IDs, electrical schematics, and mechanical drawings</li><li>Knowledge of preventive and predictive maintenance methodologies</li></ul>GMP &amp; Regulatory Knowledge<ul><li>Thorough understanding of EU GMP requirements for pharmaceutical manufacturing</li><li>Knowledge of equipment qualification (IQ/OQ/PQ) processes</li><li>Familiarity with change control, deviation management, and CAPA systems</li><li>Understanding of cleanroom classifications and environmental monitoring</li><li>Documentation practices as per GMP guidelines</li></ul>PREFERRED QUALIFICATIONS<ul><li>Experience with effervescent tablet manufacturing equipment</li><li>Experience with regulatory inspections (WHO GMP, EU GMP)</li><li>Understanding of pharmaceutical validation protocols and regulatory requirements</li></ul>CORE COMPETENCIESTechnical Competencies<ul><li>Equipment troubleshooting and problem-solving</li><li>Preventive and breakdown maintenance execution</li><li>Technical documentation and record-keeping</li><li>Equipment performance analysis</li><li>Vendor coordination and management</li></ul>Quality &amp; Compliance<ul><li>EU GMP compliance mindset</li><li>Attention to detail and documentation rigor</li><li>Process understanding and quality consciousness</li><li>Regulatory awareness</li><li>Risk assessment capabilities</li></ul>Professional Competencies<ul><li>Analytical and logical thinking</li><li>Time management and prioritization</li><li>Team collaboration</li><li>Communication skills (verbal and written)</li><li>Learning agility and adaptability</li><li>Safety consciousness</li><li>Ownership and accountability</li></ul>Job Types: Full-time, PermanentPay: ₹40,000.00 - ₹60,000.00 per monthWork Location: In person

Maintenance Engineer - Solid Oral Dosage

ORGANIZATIONAL DETAILSCompany: Sushen Medicamentos Pvt. Ltd. Department: Projects &amp; Maintenance - Sterile Manufacturing Location: Ahmedabad, Gujarat Reports To: Maintenance and Projects Head Position Type: Full-Time, Permanent Experience Level: 4-5 Years (Mandatory: EU GMP Approved Plant Experience)ABOUT SUSHEN MEDICAMENTOSSushen Medicamentos Pvt. Ltd. is a globally recognized pharmaceutical services company specializing in:<ul><li>Pharmaceutical Project Management Services (PMS): Complete turnkey solutions for manufacturing infrastructure including sterile facilities</li><li>Contract Development and Manufacturing Organization (CDMO): Specialized manufacturing services across multiple dosage forms</li></ul>Operating under stringent regulatory standards including cGMP, WHO-GMP, USFDA, and EMA compliance, Sushen maintains world-class pharmaceutical manufacturing capabilities with particular expertise in sterile product manufacturing.POSITION SUMMARYThe IV Fluid Projects &amp; Maintenance Engineer will be responsible for dual functions: executing engineering projects for IV fluid manufacturing facility setup/expansion and ensuring optimal maintenance of sterile manufacturing equipment and critical utilities. This role demands specialized expertise in aseptic processing, sterile manufacturing environments, and stringent EU GMP compliance for injectable products.The position requires hands-on experience with IV fluid/sterile injectable manufacturing equipment, cleanroom systems, and critical utility management in EU GMP approved pharmaceutical facilities. The engineer will play a crucial role in both maintaining existing operations and implementing new projects for capacity expansion or technology upgrades.KEY RESPONSIBILITIESA. PROJECT EXECUTION Sterile Facility Projects<ul><li>Execute engineering projects for IV fluid manufacturing facility setup, expansion, and modernization including:</li><li>Cleanroom construction and upgrades (Grade A, B, C, D areas)</li><li>Installation of sterile manufacturing equipment</li><li>Utility systems installation and upgrades</li><li>Process equipment integration and commissioning</li><li>Automation and control system implementation</li><li>Prepare detailed project plans with timelines, milestones, and resource requirements</li><li>Coordinate with cross-functional teams (Production, QA, Regulatory, EHS) for project execution</li><li>Manage equipment procurement process including vendor selection and technical evaluation</li><li>Oversee installation, commissioning, and qualification activities (IQ/OQ/PQ)</li><li>Ensure projects comply with EU GMP requirements for sterile manufacturing facilities</li></ul>Equipment Installation &amp; QualificationLead installation of IV fluid manufacturing equipment:<ul><li>Ampoule/vial washing and depyrogenation systems</li><li>Filling and sealing machines (ampoules, vials, IV bags, IV Bottles)</li><li>Autoclave/sterilization equipment</li><li>Inspection systems (visual and automated)</li><li>Labeling and packaging lines</li><li>Material handling systems for sterile areas</li></ul><ul><li>Execute Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)</li><li>Develop and execute qualification protocols (IQ/OQ/PQ) as per EU GMP requirements</li><li>Coordinate validation activities with Quality Assurance team</li><li>Prepare comprehensive project documentation and as-built drawings</li></ul>Utilities &amp; Critical Systems Projects<ul><li>Implement critical utility systems:</li><li>Water for Injection (WFI) generation and distribution systems</li><li>Clean Steam generation and distribution</li><li>HVAC systems for cleanrooms with HEPA filtration</li><li>Compressed air systems (instrument air, breathing air)</li><li>Nitrogen and other utility gases</li><li>Pure steam generators</li><li>Clean-in-Place (CIP) and Sterilize-in-Place (SIP) systems</li><li>Manage DQ (Design Qualification) for utility systems</li><li>Ensure compliance with pharmacopeial requirements (USP, EP) for utilities</li></ul>B. MAINTENANCE OPERATIONS (50-60% of Role)Sterile Manufacturing Equipment Maintenance<ul><li>Execute preventive and corrective maintenance on IV fluid manufacturing equipment:</li><li>Washing Equipment: Ampoule/vial washing machines, tunnel washers</li><li>Depyrogenation Equipment: Dry heat sterilizers, depyrogenation tunnels</li><li>Filling Systems: Aseptic filling machines, blow-fill-seal (BFS) systems, form-fill-seal machines</li><li>Sealing Equipment: Ampoule sealing, vial capping machines</li><li>Sterilization Equipment: Autoclaves (steam sterilizers), dry heat ovens, pure steam generators</li><li>Inspection Systems: Manual/semi-automatic/automatic inspection machines, leak testing equipment</li><li>Labeling &amp; Packaging: Labelers, cartoning machines, case packers</li><li>Material Transfer Systems: Pass-through chambers, LAF units, material airlocks</li><li>Maintain Grade A/B Isolators and Restricted Access Barrier Systems (RABS) if applicable</li><li>Troubleshoot complex equipment breakdowns with minimal production impact</li><li>Coordinate with equipment OEMs for specialized technical support</li><li>Maintain equipment logbooks and history cards as per GMP requirements</li></ul>Critical Utilities Maintenance<ul><li>Ensure 24/7 availability of critical utilities supporting sterile manufacturing:</li><li>WFI Systems: Generation (distillation/RO+EDI), storage, and hot/cold loop distribution</li><li>Clean Steam Systems: Generation and distribution for sterilization</li><li>HVAC Systems: AHUs, HEPA filters, differential pressure control, temperature and humidity management</li><li>Compressed Air: Oil-free compressors, dryers, filtration systems</li><li>CIP/SIP Systems: Automated cleaning and sterilization systems</li><li>Environmental Monitoring Systems: Particle counters, microbial monitoring, pressure differential monitors</li><li>Monitor critical utility parameters and maintain within specified limits</li><li>Execute preventive maintenance schedules for all utility systems</li><li>Manage emergency response for utility failures</li></ul>Electrical/Mechanical Systems ManagementFor Electrical -<ul><li>Maintain electrical systems in classified cleanroom areas with explosion-proof/safe area requirements</li><li>Troubleshoot PLC-based control systems for sterile manufacturing equipment</li><li>Manage automation systems including recipe management, batch control, and data logging</li><li>Maintain UPS systems ensuring uninterrupted power to critical equipment</li><li>Handle electrical qualification and calibration of instruments</li><li>Ensure proper functioning of cleanroom monitoring systems (particle counters, pressure differential monitors)</li><li>Maintain electrical interlocks and safety systems in aseptic areas</li></ul>For Mechanical -<ul><li>Maintain mechanical systems of filling machines, sealers, and washing equipment</li><li>Manage steam systems, condensate recovery, and steam traps</li><li>Maintain pumps, valves, and piping systems for WFI and clean steam</li><li>Handle alignment, balancing of high-speed filling and sealing equipment</li><li>Manage compressed air systems and gas distribution networks</li><li>Maintain material handling systems and cleanroom pass-throughs</li></ul>EU GMP Compliance &amp; Documentation<ul><li>Execute all maintenance and project activities in strict compliance with EU GMP Annex 1 (Sterile Medicinal Products)</li><li>Maintain comprehensive GMP documentation:</li><li>Preventive maintenance schedules and execution records</li><li>Calibration certificates and schedules</li><li>Equipment qualification documentation (IQ/OQ/PQ)</li><li>Change control for equipment modifications</li><li>Deviation and CAPA records</li><li>Project documentation and validation reports</li><li>SOPs for equipment operation and maintenance</li><li>Equipment cleaning and sterilization records</li><li>Support regulatory audits (EMA, USFDA, MHRA, WHO) with technical documentation</li><li>Ensure maintenance activities maintain cleanroom integrity and sterility assurance</li><li>Follow gowning protocols and aseptic behavior in Grade A/B areas</li><li>Participate in environmental monitoring and contamination control programs</li></ul>C. TECHNICAL SUPPORT &amp; CONTINUOUS IMPROVEMENTProcess Support<ul><li>Provide technical support during production operations for equipment-related issues</li><li>Participate in batch investigations and failure analysis</li><li>Support new product introductions and process validations</li><li>Assist in media fills and aseptic process simulations</li><li>Contribute to risk assessments (FMEA, HACCP) for sterile processes</li></ul>Improvement Initiatives<ul><li>Identify opportunities for equipment reliability enhancement</li><li>Participate in root cause analysis for equipment failures and contamination events</li><li>Implement predictive maintenance strategies (vibration analysis, thermography, oil analysis)</li><li>Support technology upgrades and automation projects</li><li>Contribute to energy efficiency and sustainability initiatives</li></ul>Vendor &amp; Spare Parts Management<ul><li>Coordinate with equipment vendors and service providers</li><li>Manage spare parts inventory for critical sterile manufacturing equipment</li><li>Evaluate and qualify vendors for maintenance services</li><li>Support annual maintenance contracts (AMCs) and service agreements</li></ul>D. SAFETY &amp; COMPLIANCE<ul><li>Ensure compliance with electrical/mechanical safety standards in cleanroom environments</li><li>Follow lockout-tagout (LOTO) procedures for equipment isolation</li><li>Maintain EHS compliance including chemical safety, steam safety, and confined space entry</li><li>Participate in safety training and incident investigations</li><li>Ensure proper handling of hazardous materials (cleaning agents, sanitizers)</li><li>Maintain housekeeping and 5S standards in maintenance areas</li></ul>REQUIRED QUALIFICATIONSEducation<ul><li>Bachelor's degree in Electrical Engineering OR Bachelor's degree in Mechanical Engineering (B.E./B.Tech)</li></ul>Experience<ul><li>Total Experience: 4-5 years in projects and/or maintenance engineering roles</li><li>Mandatory Requirement: Minimum 3 years of hands-on experience in EU GMP approved pharmaceutical manufacturing plants</li><li>Sterile Products Experience: Proven experience with IV fluids, large volume parenterals (LVP), small volume parenterals (SVP), or injectable manufacturing</li><li>Project Experience: Demonstrated experience in equipment installation, commissioning, or facility projects (preferred)</li></ul>Technical SkillsSterile Manufacturing Expertise:<ul><li>Hands-on experience with aseptic filling equipment (ampoules, vials, IV bags, IV Bottles , BFS systems)</li><li>Knowledge of sterilization processes (moist heat, dry heat, filtration)</li><li>Understanding of depyrogenation principles and equipment</li><li>Familiarity with cleanroom design, HVAC systems, and environmental control</li><li>Experience with WFI and clean steam systems</li><li>Knowledge of CIP/SIP systems and validation</li></ul>Core Technical Competencies:<ul><li>Equipment installation, commissioning, and qualification</li><li>Troubleshooting complex sterile manufacturing equipment</li><li>Reading and interpreting P&amp;IDs, electrical schematics, and mechanical drawings</li><li>Project planning and execution</li><li>Preventive and predictive maintenance methodologies</li></ul>GMP &amp; Regulatory Knowledge<ul><li>Mandatory: Thorough understanding of EU GMP requirements, particularly Annex 1 (Manufacture of Sterile Medicinal Products)</li><li>Knowledge of equipment qualification and process validation principles</li><li>Understanding of cleanroom classifications (ISO 14644, EU GMP Grade A/B/C/D)</li><li>Familiarity with pharmacopeial requirements (USP, EP) for sterile products</li><li>Change control, deviation management, and CAPA systems</li><li>Documentation practices for GMP compliance</li><li>Understanding of contamination control strategies</li></ul>PREFERRED QUALIFICATIONS<ul><li>Experience with multiple sterile dosage forms (ampoules, vials, pre-filled syringes, IV bags)</li><li>Exposure to Blow-Fill-Seal (BFS) or Restricted Access Barrier Systems (RABS) technology</li><li>Knowledge of isolator technology for aseptic processing</li><li>Experience with regulatory inspections (EMA, USFDA, MHRA)</li><li>Familiarity with CMMS systems (SAP PM, Maximo)</li><li>Training in Lean Manufacturing, Six Sigma, or TPM</li><li>Understanding of pharmaceutical water systems (Purified Water, WFI, Clean Steam)</li><li>Experience with lyophilization (freeze-drying) equipment</li><li>Knowledge of Building Management Systems (BMS) and Building Automation Systems (BAS)</li><li>Project management certification (PMP/Prince2) - advantage</li></ul>CORE COMPETENCIESTechnical Competencies<ul><li>Sterile manufacturing equipment expertise</li><li>Project planning and execution</li><li>Equipment troubleshooting and problem-solving</li><li>Qualification and validation protocol development</li><li>Technical documentation and GMP record-keeping</li><li>Vendor and contractor management</li><li>Critical utilities management</li></ul>Quality &amp; Compliance<ul><li>EU GMP Annex 1 compliance mindset</li><li>Aseptic technique understanding</li><li>Contamination control awareness</li><li>Risk-based thinking</li><li>Regulatory compliance orientation</li><li>Documentation rigor and attention to detail</li></ul>Professional Competencies<ul><li>Project management skills</li><li>Analytical and problem-solving abilities</li><li>Multi-tasking and prioritization</li><li>Cross-functional collaboration</li><li>Communication skills (verbal and written)</li><li>Leadership and ownership</li><li>Adaptability and learning agility</li><li>Safety consciousness</li></ul>Job Types: Full-time, PermanentPay: ₹40,000.00 - ₹70,000.00 per monthWork Location: In person

IV Fluid Projects & Maintenance Engineer

Company: Sushen Medicamentos Pvt. Ltd. Department: Maintenance &amp; Engineering Location: Ahmedabad, Gujarat Reports To: Maintenance and Projects Head Position Type: Full-Time, Permanent Experience Level: 8-10 YearsABOUT SUSHEN MEDICAMENTOSSushen Medicamentos Pvt. Ltd. is a globally recognized pharmaceutical services company specializing in:<ul><li>Pharmaceutical Project Management Services (PMS): Turnkey solutions for manufacturing infrastructure from plant design to commissioning</li><li>Contract Development and Manufacturing Organization (CDMO): Specialized manufacturing services with expertise in effervescent tablet technology</li></ul>Operating across international markets with strict adherence to cGMP, WHO-GMP, USFDA, and EMA regulatory standards, Sushen is committed to delivering world-class pharmaceutical solutions.POSITION SUMMARYThe Assistant Manager - Maintenance (Electrical) will lead and manage the entire maintenance team at Sushen's Ahmedabad facility. This role is critical to ensuring uninterrupted manufacturing operations, regulatory compliance, and optimal performance of all electrical, electronics, and mechanical systems. The position requires a strong technical background in electrical engineering combined with pharmaceutical industry expertise and leadership capabilities.KEY RESPONSIBILITIESMaintenance Leadership &amp; Team Management<ul><li>Lead, mentor, and develop the maintenance team, ensuring optimal performance and skill development</li><li>Plan, organize, and supervise all preventive and corrective maintenance activities across the facility</li><li>Establish maintenance schedules, work priorities, and resource allocation to minimize production downtime</li><li>Conduct performance reviews, provide technical guidance, and identify training needs for team members</li><li>Foster a culture of accountability, continuous improvement, and safety within the maintenance department</li></ul>Equipment &amp; Asset Management<ul><li>Ensure optimal performance and availability of all electrical systems, HVAC, utilities, and production equipment</li><li>Develop and implement comprehensive preventive maintenance programs for all critical equipment</li><li>Manage breakdown maintenance with rapid response protocols to minimize impact on production</li><li>Maintain detailed equipment history, maintenance logs, and asset documentation</li><li>Coordinate with equipment vendors and service providers for specialized maintenance and calibration activities</li></ul>cGMP Compliance &amp; Quality Assurance<ul><li>Ensure all maintenance activities comply with cGMP, WHO-GMP, EU GMP requirements</li><li>Maintain documentation and records as per pharmaceutical regulatory standards</li><li>Support regulatory audits and inspections with proper documentation and evidence</li><li>Implement and maintain change control procedures for all maintenance-related modifications</li><li>Ensure calibration schedules are maintained for all critical instruments and equipment</li></ul>Technical &amp; Project Support<ul><li>Provide technical expertise for facility expansion, equipment installation, and upgrades</li><li>Collaborate with the Maintenance and Projects Head on capital projects and facility improvements</li><li>Evaluate new technologies and equipment to enhance operational efficiency</li><li>Prepare technical specifications, vendor evaluations, and cost estimates for maintenance projects</li><li>Support qualification and validation activities (IQ/OQ/PQ) for new equipment installations</li></ul>Safety &amp; Utilities Management<ul><li>Ensure compliance with electrical safety standards and industrial safety regulations</li><li>Manage utility systems including power distribution, water systems, compressed air, and HVAC</li><li>Implement energy conservation initiatives and monitor utility consumption</li><li>Conduct risk assessments and implement safety improvements in maintenance operations</li><li>Maintain emergency response readiness for critical equipment failures</li></ul>Planning &amp; Budgeting<ul><li>Develop annual maintenance budgets and monitor expenditure against approved budgets</li><li>Optimize spare parts inventory and establish vendor relationships for critical components</li><li>Prepare maintenance reports, KPIs, and performance metrics for management review</li><li>Identify cost-saving opportunities without compromising quality or compliance</li></ul>REQUIRED QUALIFICATIONSEducation<ul><li>Bachelor's degree in Electrical Engineering (B.E./B.Tech in Electrical Engineering)</li></ul>Experience<ul><li>Total Experience: 8-10 years in maintenance and engineering roles</li><li>Pharmaceutical Industry Experience: Minimum 5 years of hands-on experience in pharmaceutical manufacturing/CDMO facilities</li><li>Leadership Experience: Minimum 3 years in supervisory/team lead roles managing maintenance teams</li></ul>Technical Knowledge<ul><li>Strong expertise in electrical systems, control panels, motors, transformers, and power distribution</li><li>Thorough understanding of cGMP requirements and pharmaceutical manufacturing standards</li><li>Knowledge of HVAC systems, utilities management, and clean room operations</li><li>Familiarity with PLCs, SCADA systems, and industrial automation</li><li>Understanding of equipment qualification (IQ/OQ/PQ) and validation protocols</li></ul>Regulatory Knowledge<ul><li>Working knowledge of WHO-GMP, cGMP guidelines</li><li>Understanding of USFDA and EU GMP regulatory requirements for pharmaceutical manufacturing</li><li>Experience with regulatory audits and inspection preparedness</li></ul>CORE COMPETENCIESTechnical Competencies<ul><li>Electrical systems troubleshooting and diagnostics</li><li>Preventive and predictive maintenance methodologies</li><li>Equipment reliability and asset management</li><li>Project management and execution</li><li>Technical documentation and SOP development</li></ul>Leadership &amp; Management<ul><li>Team building and people development</li><li>Performance management and accountability</li><li>Decision-making under pressure</li><li>Resource planning and optimization</li><li>Cross-functional collaboration</li></ul>Quality &amp; Compliance<ul><li>GMP compliance mindset</li><li>Attention to detail and documentation rigor</li><li>Root cause analysis and CAPA implementation</li><li>Continuous improvement orientation</li><li>Risk assessment and mitigation</li></ul>Behavioral Competencies<ul><li>Problem-solving and analytical thinking</li><li>Communication and interpersonal effectiveness</li><li>Adaptability and resilience</li><li>Safety consciousness</li><li>Results orientation</li></ul>Job Types: Full-time, PermanentPay: ₹60,000.00 - ₹75,000.00 per monthWork Location: In person

Asst.Manager - Maintenance ( Electrical)

Join Sushen Medicamentos and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Sushen Medicamentos

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Maintenance Engineer - Solid Oral Dosage

IV Fluid Projects & Maintenance Engineer

Asst.Manager - Maintenance ( Electrical)