Role & responsibilities

1. To follow the Good Manufacturing Practices (GMP), Data Integrity (DI) and Valuable Documentation Practices (GDP) to ensure compliance and safety precautions.

2. Responsible for Process Improvements:

a. Identify bottlenecking equipment by monitoring the process and reduce the time cycle by process engineering calculations, line modifications and incorporating new technologies.

b. Exploring for contemporary technologies (contacting external parties if required), generate the technical specifications/Design specifications.

c. Technical evaluation of Equipments, Equipment procurement,

d. Coordinate with CFT for operational & process improvements for better outcomes.

3. Responsible for Manufacturing Excellence.

a. Study yield trends and identify critical factors impacting yield variations and to eliminate / reduce yield variations. Calculate batch cycle time, identify bottlenecks.

b.



Identifying operational excellence projects in line with Organizational priorities.

4. Responsible for Scale-up & Validation Support:

a. Communicate the information to production, monitor the batches during production.

b. Information sharing to the operating personal and supervisor staff on the new process development.

c. Mapping of Equipments for Generics new products validation, monitoring the Lab batches and supporting in Tech transfer of new products.

d. Preparation of Manufacturing Cost Proposals for the Generics new products.

5. Responsible for Risk management:

a. To carry out need based risk assessment as per SOP.

6. Responsible for Create Safety awareness:

a. Participate in process hazard analysis (PHA) & risk analysis for new products, new facility & scale-up facility and incident investigation report.

📌 Technical Service Engineer | Vishakapatnam Location (Visakhapatnam)
🏢 Aragen Life Sciences
📍 Visakhapatnam