Process - Equipment ( OSD)

JobItUs; Pithampur; On-site; INR 1,800,000 - 2,400,000; Full time

Benefits offered by this job

On duty Lunch

PF

Mediclaim

Paid leaves

Job summary

JobItUs in India seeks a senior Process Design & Equipment professional for OSD pharma manufacturing. The role covers design, development, integration of processing equipment and systems, and ensuring regulatory compliance across USFDA, EU GMP, MHRA and WHO standards.

Lead commissioning, qualification, tech transfer, and vendor management while coordinating with CQV teams to meet project milestones and quality requirements.

Qualifications

• Experience in process design for oral solid dosage (OSD) manufacturing.
• Ability to define PFDs, P&IDs, material flow and equipment lists.
• Prepare URS for process equipment and systems.
• Evaluate manufacturing technologies for granulation, coating, compression and containment.
• Ensure designs comply with cGMP, GEP, data integrity and contamination control.

Responsibilities

• Lead concept to detailed engineering for OSD manufacturing processes.
• Oversee procurement, installation and integration of dispensing booths, granulators, fluid bed dryers, blenders, tablet presses and coating machines.
• Coordinate with OEMs for reviews, FATs/SATs and timely delivery.
• Manage interface between process equipment and HVAC, utilities, electrical and automation.
• Review layouts, GA drawings and hook-up details for installability.

Skills

Process design

Equipment integration

Capacity planning

Regulatory compliance

Vendor management

Project coordination

GMP/GEP

Education

BE Mechanical

BE Chemical

Job description

• • Designation – Process - Equipment ( OSD)
  • Qualification – BE Mechanical/ Chemical
  • Work Timings –9 hours
  • Working Days – Monday toSaturday
  • 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 Professional.
• Training in GMP, Validation, and Regulatory Compliance.
• Project Management Certification (PMP / PRINCE2).