Job Description

We are seeking a highly skilled and motivated Process Engineer to join our pharmaceutical manufacturing team. The Process Engineer will play a crucial role in optimizing manufacturing processes, ensuring product quality, and improving operational efficiency. This position requires a deep understanding of pharmaceutical manufacturing principles, process engineering, and regulatory compliance.

Key Responsibilities

Process Optimization:

• Develop, evaluate, and optimize manufacturing processes to enhance efficiency, quality, and cost-effectiveness.
  
• Identify and implement process improvements to reduce waste, increase yield, and improve overall production performance.
  

Quality Assurance:

• Ensure all manufacturing processes comply with Good Manufacturing Practices (GMP), regulatory standards, and company quality policies.
  
• Conduct root cause analysis and corrective actions for process deviations and non-conformances.
  

Technical Support:

• Provide technical support to production teams, troubleshoot process-related issues, and recommend solutions.
  
• Collaborate with R&D, Quality Control, and other departments to ensure smooth technology transfer and process validation.
  

Documentation and Compliance:

• Prepare and maintain detailed documentation, including Standard Operating Procedures (SOPs), process flow diagrams, and validation protocols.
  
• Ensure compliance with all regulatory requirements, including FDA, EMA, and other relevant agencies.
  

Project Management:

• Lead or participate in cross-functional project teams to develop and implement new processes, equipment, and technologies.
  
• Manage project timelines, budgets, and resources effectively to ensure successful project completion.
  

Continuous Improvement:

• Drive continuous improvement initiatives by implementing Lean Manufacturing, Six Sigma, and other methodologies.
  
• Conduct regular process audits and reviews to identify areas for improvement and implement best practices.
  

Requirements

Education: Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or a related field.

Experience:

• Minimum of 5+ years of experience in process engineering within a pharmaceutical manufacturing environment.
  
• Experience with process optimization, scale-up, and validation in a GMP-regulated setting.
  
• Strong background working with Emerson DCS, SCADA, Siemens or Allen Bradley PLCs, MES, LIMS, BMS, ERPs
  
• Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams.
  
• Knowledge of regulatory requirements and quality systems in the pharmaceutical industry.
  
• Ability to manage multiple projects and prioritize tasks in a fast-paced environment.
  

Preferred Qualifications

• Certified Lean Six Sigma Green Belt or Black Belt.
  

Job Tags

Similar Jobs