Senior Process Engineer

Title:

Senior
Process Engineer – Pharmaceutical Industry

Location:

Remote

Experience:

2+ years

We are looking for a motivated and detail-oriented Senior Process Engineer to join our pharmaceutical manufacturing team. The ideal candidate will be responsible for supporting, optimizing, and improving manufacturing processes to ensure safe, efficient, compliant, and consistent production
. The role involves working closely with Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, and R&D teams to improve process performance, troubleshoot manufacturing issues, and implement continuous improvement initiatives in accordance with GMP and regulatory requirements
.

• Develop, optimize, and monitor pharmaceutical manufacturing processes to achieve consistent product quality and process efficiency.
• Participate in process optimization, scale-up, technology transfer, and process validation activities.
• Support manufacturing investigations, deviations, CAPA, change controls, and root-cause analysis related to process performance.
• Identify and implement Continuous Improvement (CI) initiatives to improve productivity, yield, cycle time, capacity, and cost efficiency.
• Prepare and review process-related documents, including SOPs, batch manufacturing records, process descriptions, protocols, reports, and technical documents.
• Work closely with QA to ensure processes and documentation comply with GMP, SOPs, and applicable regulatory requirements
  .
• Support equipment qualification, cleaning validation, process validation, and other validation activities as required.
• Monitor critical process parameters (CPPs) and critical quality attributes (CQAs) and support process control strategies.
• Conduct risk assessments such as FMEA and identify appropriate process controls and mitigation measures.
• Promote a strong culture of safety, quality, compliance, and continuous improvement within manufacturing operations.

• Strong understanding of pharmaceutical manufacturing processes and GMP requirements
  .
• Knowledge of process validation, technology transfer, scale-up, and process optimization.
• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, or a related field
  .