01Key Responsibilities
Lead process design and detailed engineering for OSD manufacturing areas including dispensing, granulation, blending, compression, coating, capsule filling, inspection and packing.
Prepare/review PFDs, P&IDs;, equipment lists, material flow and URS.
Handle process equipment specification, procurement, installation, integration and commissioning.
Work with OEMs/vendors on design reviews, FAT/SAT, technical clarifications and equipment execution.
Evaluate equipment for granulation, drying, blending, compression, coating, capsule filling, containment and material handling.
Support capacity planning, process optimization, scale-up, technology transfer and debottlenecking.
Lead/support qualification and validation activities including DQ, IQ, OQ and PQ.
Ensure compliance with cGMP, GEP, USFDA, EU GMP, MHRA, WHO, PIC/S and Schedule M requirements.
Coordinate with QA, QC, Manufacturing, Warehouse, EHS, Automation, HVAC, MEP and Project teams.
Participate in HAZOP, risk assessments, design reviews and project execution activities.
Ideal Candidate:
Strong hands-on experience in OSD process design and equipment engineering
Expertise in tablet, capsule, granulation, coating and packaging technologies
Experience with containment, dust extraction and material handling systems
Knowledge of GMP, validation, HVAC classifications and regulatory requirements
Experience in commissioning, qualification and technology transfer
Strong vendor, OEM and stakeholder management skills
Experience in pharmaceutical project execution / turnkey projects will be preferred
Additional Advantage: Six Sigma / Lean, GMP & Validation training, PMP/PRINCE2 certification.
Employment: Payroll of Talisman HR Solutions
Contract: Auto-renewable based on performance .
