Process Engineer

Roles & Responsibilities

• Support daily manufacturing operations and troubleshoot process issues.
• Analyze production data to identify process improvement opportunities.
• Develop and update manufacturing procedures and work instructions.
• Lead process validation and equipment qualification activities.
• Collaborate with Quality on deviation investigations and CAPAs.
• Monitor KPIs and recommend corrective actions.
• Support technology transfer and new product introductions.
• Participate in risk assessments and continuous improvement initiatives.
• Ensure compliance with GMP, FDA, and company policies.
• Provide technical support to manufacturing personnel.

Requirements

• 35 years of manufacturing or process engineering experience.
• Experience in pharmaceutical, biotechnology, or medical device industries.
• Knowledge of Lean Manufacturing principles.
• Experience with process validation activities.
• Bachelor's Degree in Chemical, Mechanical, Industrial, or Manufacturing Engineering.

Mandatory Skills / Competencies

• GMP Compliance
• Process Validation
• Root Cause Analysis
• CAPA
• Data Analysis
• Cross-functional Collaboration
• Problem Solving