Job Description

The Senior Engineer, Oral Solid Dosage (OSD) Manufacturing Science and Technology (MSAT), serves as the process technical authority for critical OSD unit operations, with a primary focus on blending, tablet compression, and low‑shear wet granulation via top‑down spray fluid bed systems.

This role is responsible for deep technical ownership of these processes across the product lifecycle, including commercial manufacturing support, technology transfer, troubleshooting, process optimization, and continuous improvement. The position partners closely with Manufacturing, Quality, Engineering, and Process Development to ensure robust, compliant, and capable processes that consistently deliver high‑quality product.

The ideal candidate is a recognized subject matter expert (SME) who can translate scientific and engineering principles into practical, shop‑floor solutions while maintaining strong regulatory and GMP alignment.

Process Technical Ownership (Primary Focus)

• Serve as the process SME for OSD unit operations with specific depth and expertise in:
  • Powder blending and blend uniformity control
  • Tablet compression (including tool design considerations, scale effects, and defect mitigation)
  • Low‑shear wet granulation using top‑down spray fluid bed technology (process design, scale‑up, and robustness)
• Own process understanding, control strategies, and operating envelopes for assigned products and unit operations.
• Provide real‑time technical decision‑making during manufacturing events, deviations, and atypical process behavior.

Manufacturing Support & Troubleshooting

• Provide hands‑on, floor‑based technical support for commercial OSD manufacturing operations.
• Lead complex troubleshooting efforts related to:
  • Flow, segregation, and blend uniformity challenges
  • Compression defects (e.g., capping, lamination, sticking, weight variability)
  • Fluid bed granulation issues including spray distribution, granule growth, agglomeration, and drying behavior
• Perform structured root cause analysis and define sustainable corrective and preventive actions (CAPAs).

Technology Transfer & Process Scale‑Up

• Act as the technical lead for technology transfer activities involving blending, granulation, and compression processes.
• Ensure process knowledge, critical parameters, and control strategies are effectively translated from development into commercial manufacturing.
• Support scale‑up activities, process validation, and PPQ execution with strong scientific rationale.

Continuous Improvement & Process Optimization

• Lead and participate in continuous improvement initiatives focused on process capability, yield, cycle time, and product quality.
• Apply statistical and data‑driven approaches to evaluate process performance and variability.
• Identify opportunities for equipment, parameter, or procedural improvements aligned with product and site objectives.

Documentation & Regulatory Support

• Author, review, and approve technical documentation including:
  • Batch records and master manufacturing instructions
  • SOPs and technical reports
  • Validation, deviation, and investigation documentation
• Provide technical input and support for regulatory submissions, inspections, and internal audits.
• Ensure all activities align with GMP requirements and applicable regulatory expectations.

Cross‑Functional Collaboration

• Partner closely with Manufacturing, Quality Assurance, Quality Control, Engineering, Supply Chain, and Process Development teams.
• Serve as a trusted technical advisor, translating complex process concepts into clear, actionable guidance for diverse stakeholders.
• Support implementation of new technologies, equipment, and process improvements on the manufacturing floor.

Education

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related technical discipline (advanced degree preferred).

Experience

• 5–10+ years of pharmaceutical manufacturing experience with a strong emphasis on oral solid dosage forms.
• Demonstrated, hands‑on expertise in:
  • Blending operations
  • Tablet compression processes
  • Low‑shear wet granulation using top‑down spray fluid bed systems
• Experience supporting commercial manufacturing in a GMP environment is required.

Technical Skills & Knowledge

• Strong understanding of OSD process science, unit operations, and equipment design.
• Proven ability to apply process understanding to troubleshooting and optimization.
• Experience using data analysis tools for process monitoring and improvement; familiarity with JMP and statistical methods preferred.
• Knowledge of GMP, FDA regulations, and pharmaceutical industry best practices.

Professional Competencies

• Strong problem‑solving and root cause analysis skills.
• Clear and effective written and verbal communication.
• Ability to work independently as a technical expert while collaborating effectively in cross‑functional teams.
• Comfortable operating both at the strategic level and in hands‑on manufacturing environments.

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