Process Engineer – Dry External Manufacturing(Pharma)

Key Responsibilities

Process & Manufacturing Support

• Provide technical support to external manufacturers producing tablets and capsules.
• Develop, maintain, and enhance process and equipment knowledge for dry product manufacturing operations.
• Apply engineering principles to improve process understanding, capability, efficiency, and reliability.
• Monitor process performance and identify opportunities for optimization and productivity improvements.
• Support manufacturing scale-up, process qualification, and commercialization activities.

Process Troubleshooting & Root Cause Analysis

• Lead or participate in investigations related to manufacturing deviations, operational issues, and process failures.
• Perform systematic root cause analysis and implement effective corrective and preventive actions (CAPAs).
• Identify process knowledge gaps impacting equipment performance and manufacturing robustness.
• Drive countermeasures to address recurring operational and supply reliability concerns.

Continuous Improvement

• Utilize Statistical Process Control (SPC), Six Sigma, and Lean methodologies to improve process performance.
• Analyze manufacturing data and trends to support engineering decisions.
• Identify cost reduction and operational efficiency opportunities.
• Support implementation of continuous improvement projects at external manufacturing sites.

HSE & Process Safety Management

• Provide oversight for Health, Safety & Environment (HSE) and Process Safety Management (PSM) programs at contract manufacturing sites.
• Support investigations related to FUME systems and operational incidents.
• Ensure ongoing visibility and qualification status of critical manufacturing and safety systems.
• Promote a strong culture of safety and regulatory compliance.

Cross-Functional Collaboration

• Act as a technical representative within Joint Process Teams (JPTs).
• Collaborate with Quality, Engineering, Manufacturing, Supply Chain, and External Manufacturing teams.
• Communicate technical findings and recommendations to multiple stakeholders.
• Support audits, inspections, and manufacturing site visits as required.

Experience

• Minimum 8 years of experience in pharmaceutical manufacturing/process engineering.
• Experience in solid oral dosage manufacturing (tablets and capsules).
• Strong knowledge of dry product manufacturing operations and equipment.