Production Process Engineer

2 days ago

Hyderabad, Telangana, India Pardha Constrcution Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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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