Hiring - Process - Equipment ( OSD) - Pharma Industry

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 safe 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).