:

- - Designation – Process - Equipment ( OSD)

- Qualification – BE Mechanical/ Chemical

- Work Timings – 9 hours

- Working Days – Monday to Saturday

- Work Location – Pithampur

- Salary (Min & Max) – Best in industry

- Experience – 5+ years

- Benefits - On duty Lunch, PF, Mediclaim, Paid leaves

Note: This role will be on payroll of Talisman HR Solutions

Auto renewable contract based on performance

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 Qualified.

- Training in GMP, Validation, and Regulatory Compliance.

- Project Management Certification (PMP / PRINCE2).

📌 Hiring - Process - Equipment ( OSD) - Pharma Industry (Pithampur)
🏢 Talisman HR Solutions
📍 Pithampur