Job
Description
As a Production Process Engineer with 3 to 6 years of experience in pharmaceutical manufacturing, your role will involve optimizing production processes, troubleshooting technical issues, and ensuring adherence to cGMP standards. Key Responsibilities: - Improve and monitor manufacturing processes to enhance productivity, efficiency, and product consistency while minimizing waste and downtime. - Investigate and resolve production issues such as deviations, yield variations, and equipment malfunctions to ensure smooth operations. - Support the preparation and execution of process validation protocols (IQ/OQ/PQ) and ensure timely documentation in line with cGMP and regulatory standards. - Ensure strict compliance with GMP, SOPs, and all applicable regulatory guidelines (e.g., FDA, EU-GMP, ICH). - Assist in the scale-up and technology transfer of new products from R&D or other sites to commercial production. - Work closely with QA, QC, Engineering, R&D, and EHS teams to support operations and implement corrective and preventive actions (CAPA). - Participate in Lean Manufacturing and Six Sigma initiatives to identify process improvement opportunities and cost-saving measures. - Participate in equipment qualification, troubleshooting, and ongoing maintenance planning to ensure reliable operation. Required Qualifications: - Bachelors degree in Chemical Engineering, Pharmaceutical Engineering, or related field. - 3 to 6 years of relevant experience in a pharmaceutical manufacturing environment. - Strong knowledge of cGMP, FDA, EU GMP, and other regulatory frameworks. - Experience with process validation, batch documentation, deviation handling, and change control systems. - Familiarity with solid oral dosage, sterile, or API production processes (customizable per your site). - Good understanding of production equipment and cleanroom requirements. - Proficient in MS Office tools; experience with ERP/MES systems is an advantage. As a Production Process Engineer with 3 to 6 years of experience in pharmaceutical manufacturing, your role will involve optimizing production processes, troubleshooting technical issues, and ensuring adherence to cGMP standards. Key Responsibilities: - Improve and monitor manufacturing processes to enhance productivity, efficiency, and product consistency while minimizing waste and downtime. - Investigate and resolve production issues such as deviations, yield variations, and equipment malfunctions to ensure smooth operations. - Support the preparation and execution of process validation protocols (IQ/OQ/PQ) and ensure timely documentation in line with cGMP and regulatory standards. - Ensure strict compliance with GMP, SOPs, and all applicable regulatory guidelines (e.g., FDA, EU-GMP, ICH). - Assist in the scale-up and technology transfer of new products from R&D or other sites to commercial production. - Work closely with QA, QC, Engineering, R&D, and EHS teams to support operations and implement corrective and preventive actions (CAPA). - Participate in Lean Manufacturing and Six Sigma initiatives to identify process improvement opportunities and cost-saving measures. - Participate in equipment qualification, troubleshooting, and ongoing maintenance planning to ensure reliable operation. Required Qualifications: - Bachelors degree in Chemical Engineering, Pharmaceutical Engineering, or related field. - 3 to 6 years of relevant experience in a pharmaceutical manufacturing environment. - Strong knowledge of cGMP, FDA, EU GMP, and other regulatory frameworks. - Experience with process validation, batch documentation, deviation handling, and change control systems. - Familiarity with solid oral dosage, sterile, or API production processes (customizable per your site). - Good understanding of production equipment and cleanroom requirements. - Proficient in MS Office tools; experience with ERP/MES systems is an advantage.
