Hiring - Process - Equipment ( OSD) - Pharma Industry …, Pithampur

Job Description:
- Work Location: Pithampur
- Days of working
- 6 days
- Shift timings
- 9 hrs duty
- Salary
- Best in the market
- Benefits
- Pf , Mediclaim , Insurance
- Gender: Male
- Payroll
- Talisman HR Solutions Key Responsibilities: 1. Process Design & Development
- Lead process design activities from conceptualization to detailed engineering for OSD manufacturing areas including dispensing, granulation, blending, compression, coating, capsule filling, inspection, and packing.
- Define process philosophies, process flow diagrams (PFDs), P&IDs;, material flow, and equipment lists based on product and capacity requirements.
- Prepare and review User Requirement Specifications (URS) for all process equipment and systems.
- Evaluate manufacturing technologies for granulation (wet/dry), coating, compression, containment, and material handling to ensure scalability and efficiency.
- Ensure process designs comply with cGMP, GEP, data integrity, containment, and contamination control requirements. 2. Process Equipment & System Integration
- Oversee specification, procurement, installation, and integration of OSD process equipment including:
- Dispensing booths
- Granulators
- Fluid bed dryers
- Blenders
- Tablet compression machines
- Coating machines
- Capsule filling machines
- IPC systems
- Packing lines
- Dust extraction systems
- Material handling systems
- Coordinate with OEMs and vendors for equipment design reviews, customization, FATs/SATs, and timely delivery.
- Ensure proper interface management between process equipment, HVAC, utilities, electrical, and automation systems.
- Review equipment layouts, GA drawings, and hook-up details to ensure smooth installation and maintainability. 3. Capacity Planning & Process Optimization
- Assess and validate plant capacities, batch sizes, machine throughput, and overall process efficiency.
- Identify process bottlenecks and implement optimization or debottlenecking initiatives.
- Support process scale-up, technology transfer, and commercial manufacturing readiness.
- Contribute to long-term production planning and flexibility for future product requirements. 4. Regulatory Compliance & Documentation
- Ensure process systems and equipment comply with applicable regulatory requirements including USFDA, EU GMP, MHRA, WHO, PIC/S, and Schedule M.
- Develop and review validation documentation including VMP, URS, DQ, IQ, OQ, and PQ protocols.
- Maintain traceability between design documents, qualification documents, and validation deliverables.
- Ensure compliance with data integrity and electronic records requirements wherever applicable. 5. Qualification, Validation & Technology Transfer
- Lead commissioning and qualification activities for all OSD process systems in coordination with CQV teams.
- Ensure successful execution of IQ/OQ/PQ as per approved validation protocols.
- Participate in FATs and SATs and ensure timely closure of observations and deviations.
- Support technology transfer activities from R&D; / F&D; to manufacturing. 6. Vendor & Stakeholder Management
- Interface with OEMs, consultants, EPC partners, and internal stakeholders including QA, QC, Manufacturing, Warehouse, EHS, and Automation teams.
- Conduct technical bid evaluations (TBE) for selection of process equipment suppliers.
- Drive vendor meetings for progress review, technical clarifications, and issue resolution.
- Ensure effective coordination between stakeholders for design approvals and execution timelines. 7. Project Execution & Coordination
- Collaborate with Project Management, Civil, MEP, HVAC, Electrical, Automation, and CQV teams for seamless project execution.
- Monitor process equipment manufacturing, delivery, installation, and commissioning activities against project schedules.
- Participate in design reviews, HAZOP reviews, risk assessments, and project progress meetings.
- Ensure adherence to change control and deviation management procedures during project execution. 8. Quality, EHS & Compliance
- Ensure all process systems are designed and executed in line with GMP, GEP, and EHS requirements.
- Implement robust contamination control strategies, dust management, and cross-contamination prevention measures.
- Ensure process systems support operator safety, ergonomic access, and safe maintenance practices.
- Promote protected work culture and compliance with EHS standards during execution and commissioning. 9. Reporting & Documentation
- Prepare weekly/monthly project progress reports highlighting milestones, risks, delays, and mitigation actions.
- Support management reviews and project status presentations for internal and external stakeholders.
- Maintain proper engineering documentation and project records. Other Experience:
- Experience in process design, engineering, and execution of OSD pharmaceutical manufacturing projects.
- Strong expertise in tablet, capsule, granulation, coating, and packaging technologies.
- Experience with containment systems, dust extraction, material handling, and process automation.
- Good understanding of cGMP, GEP, validation, HVAC classifications, and regulatory expectations.
- Hands-on experience in engineering coordination, commissioning, and qualification activities.
- Prior experience with global OEMs and turnkey pharmaceutical project execution preferred. Key Competencies:
- In-depth knowledge of Oral Solid Dosage manufacturing processes and equipment.
- Strong leadership and project coordination skills.
- Excellent technical documentation and communication abilities.
- Effective stakeholder and vendor management capabilities.
- Strong focus on quality, compliance, and operational excellence.
- Analytical problem-solving and decision-making skills under tight timelines. Preferred Certifications (Advantageous):
- Certified Six Sigma / Lean Professional.
- Training in GMP, Validation, and Regulatory Compliance.
- Project Management Certification (PMP / PRINCE2).

Name
- Willita Prashant Ved

Mail ID
- Share your CV at: Contact Number
- 77100 64829 Apply on Kit Job: kitjob.in/job/4lk431