Manufacturing Engineer

We are looking for an experienced Manufacturing Engineer to support GMP manufacturing operations in a Pharma/Biotech/Life Sciences environment. The role will focus on process improvement, equipment, troubleshooting, manufacturing support, validation, and continuous improvement.

• Support day-to-day GMP manufacturing operations and production activities.
• Improve manufacturing processes to increase quality, efficiency, yield, and productivity
  .
• Troubleshoot manufacturing equipment, process issues, and production problems.
• Support equipment installation, commissioning, qualification, and validation.
• Develop and execute IQ/OQ/PQ and process validation activities.
• Perform root cause analysis for manufacturing issues, deviations, and recurring problems.
• Support CAPA, change controls, investigations, and corrective actions
  .
• Develop and maintain SOPs, work instructions, process specifications, and manufacturing documentation.
• Analyze process data and identify opportunities for continuous improvement.
• Support new equipment, process transfers, scale-up, and new product introduction.
• Ensure manufacturing activities comply with GMP, FDA, GxP, and company procedures
  .
• Collaborate with Manufacturing, Quality, Engineering, Validation, Automation, Facilities, and R&D teams.

• Bachelor’s degree in Engineering, Manufacturing, Life Sciences
  , or related field.
• 3+ years of Manufacturing/Process Engineering experience in Pharma, Biotech, or Life Sciences.
• Strong experience working in a GMP manufacturing environment
  .
• Knowledge of manufacturing processes, equipment, utilities, and production systems.
• Experience with process validation, equipment qualification, IQ/OQ/PQ, and commissioning
  .
• Experience with GMP, CAPA, deviations, change control, and root cause analysis
  .
• Strong problem-solving, data analysis, technical documentation, and communication skills.
• Ability to work hands-on with manufacturing and cross-functional teams.