HCG - Process Engineer Pharmaceutical Manufacturing

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 costeffectiveness.
  
• 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 nonconformances.
  

• Provide technical support to production teams troubleshoot processrelated 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 crossfunctional 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 scaleup and validation in a GMPregulated 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 crossfunctional teams.
  
• Knowledge of regulatory requirements and quality systems in the pharmaceutical industry.
  
• Ability to manage multiple projects and prioritize tasks in a fastpaced environment.
  

Preferred Qualifications

• Certified Lean Six Sigma Green Belt or Black Belt.