Production Process Engineer - Pharmaceutical Industry

Job Summary:

We are looking for a qualified and motivated Production Process Engineer with 3 to 6 years of hands-on experience in pharmaceutical manufacturing. The role involves optimizing production processes, troubleshooting technical issues, and ensuring adherence to cGMP standards.

Key Responsibilities:

• Process Optimization & Control:

Improve and monitor manufacturing processes to enhance productivity, efficiency, and product consistency while minimizing waste and downtime.

• Technical Troubleshooting:

Investigate and resolve production issues such as deviations, yield variations, and equipment malfunctions to ensure smooth operations.

• Process Validation & Documentation:

Support the preparation and execution of process validation protocols (IQ/OQ/PQ) and ensure timely documentation in line with cGMP and regulatory standards.

• Compliance & GMP Adherence:

Ensure strict compliance with GMP, SOPs, and all applicable regulatory guidelines (e.g., FDA, EU-GMP, ICH).

• New Product Introduction (NPI):

Assist in the scale-up and technology transfer of new products from R&D or other sites to commercial production.

• Cross-functional Collaboration:

Work closely with QA, QC, Engineering, R&D, and EHS teams to support operations and implement corrective and preventive actions (CAPA).

• Continuous Improvement:

Participate in Lean Manufacturing and Six Sigma initiatives to identify process improvement opportunities and cost-saving measures.

• Equipment Support:

Participate in equipment qualification, troubleshooting, and ongoing maintenance planning to ensure reliable operation.
Required Qualifications:

• Bachelor’s 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.

Job Type: Full-time

Work Location: In person