HCG - Process Engineer Pharmaceutical Manufacturing

6 days ago

india Horizon Controls Group Full time
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.

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