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