
Production Process Engineer
1 day ago
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
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