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