Manager - Production

• At least 10+ years of experience in the aforementioned topics and tasks, as well as extensive experience in industrial construction.
• 4–6 years of experience in pharmaceutical manufacturing, preferably in granulation.
• Familiarity with cGMP, USFDA guidelines, and pharmaceutical documentation practices.
• Ability to read and interpret batch records and SOPs.
• You possess extensive knowledge in modern team leadership, as well as excellent communication, presentation, and moderation skills, determination, and empathy.

Key Responsibilities

1. Process & Equipment Design

• Design granulation systems (wet, dry, or fluid-bed granulation)
• Select and specify equipment like:

• High-shear granulators
• Fluid bed dryers
• Blenders and mixers

• Ensure compliance with GMP (Good Manufacturing Practice) standards

2. Construction & Installation Support

• Work with construction teams to integrate process equipment into facilities
• Oversee installation of piping, HVAC, and cleanroom systems
• Ensure proper layout for workflow, contamination control, and safety

3. Validation & Commissioning

• Perform IQ/OQ/PQ (Installation, Operational, Performance Qualification)
• Validate that granulation systems meet regulatory requirements
• Prepare documentation for audits and inspections

4. Regulatory Compliance

• Ensure compliance with authorities like:
• FDA
• EMA
• Local health authorities

5. Collaboration

• Architects & construction managers
• Pharmacists & production teams
• Quality assurance (QA/QC) teams

Required Skills & Knowledge

Technical Skills

• Understanding of granulation processes (wet, dry, roller compaction)
• Knowledge of pharmaceutical equipment and materials
• Cleanroom design and HVAC systems
• Process flow diagrams (PFDs) and piping & instrumentation diagrams (P&IDs)

Troubleshooting & Support

• Lead resolution of chronic issues: low yield, poor granule flow, inconsistent LOD, segregation, over/under granulation, capping/chipping in downstream compression.
• Execute structured RCA (5-Why, Fishbone) and implement permanent corrective actions.
• Should be able to handle troubleshooting and problem-solving, acting as the primary authority for resolving complex production issues, machine malfunctions, and deviations that arise during the granulation process.
• Should have capability for installation and commissioning of granulation equipment

Soft Skills

• Project management
• Problem-solving in regulated environments
• Strong documentation and communication skills