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ESP Engineered is seeking a skilled individual to assist in batch operations and ensure compliance with cGMP guidelines. The role requires performing in-process checks, maintaining documentation, and cooperating with the Engineering team for equipment maintenance.
The ideal candidate will have problem-solving and communication skills, and be familiar with production execution and safety protocols. Experience in operating production machinery is essential for this role.
Assist in executing batch operations as per BMR/BPR and approved SOPs.
Perform basic in-process checks like weight, thickness, hardness, fill volume, leak test, etc., depending on process.
Monitor critical parameters and inform supervisor about any abnormality.
Maintain discipline on the shop floor to avoid mix‑ups and cross‑contamination.
Fill equipment logbooks, cleaning records, process sheets, and other documents in real time.
Ensure entries are neat, complete, and as per Good Documentation Practices (GDP).
Report any errors or corrections to the Production Officer before making changes.
Receive and verify raw materials, packaging materials, and intermediates from Warehouse.
Ensure proper labeling, status identification, and segregation.
Handle materials safely—especially APIs, solvents, and sensitive ingredients.
Follow cGMP, GDP, and safety guidelines strictly.
Use required PPE such as masks, gloves, goggles, and aprons during all operations.
Follow 5S practices (Sort, Set in Order, Shine, Standardize, Sustain).
Report unsafe conditions, equipment issues, or near‑miss incidents immediately.
Assist Engineering team during preventive and breakdown maintenance.
Lubricate and inspect machine parts where applicable, under supervision.
Ensure equipment is in good mechanical condition before each batch.
Work closely with Officers, Supervisors, QA, and Engineering teams.
Report batch progress, issues, and machine abnormalities immediately.
Support during audits by maintaining area cleanliness and showing logbooks if required.
Suggest and support small process improvements to reduce waste and enhance efficiency.
Participate in training on new equipment, SOPs, and safety updates.
Operate production machinery such as granulators, blenders, tablet compression machines, coating machines, capsule fillers, liquid filling lines, sterilizers, autoclaves, etc. (as per dosage form).
Set machine parameters as instructed by the Production Officer/Supervisor.
Monitor machine performance and ensure smooth operation throughout the batch.
Perform minor troubleshooting under supervision.
Carry out cleaning of equipment and area as per SOPs (Type A/B/C cleaning, as applicable).
Arrange materials and equipment properly before starting operation.
Ensure the machine and area are clean and ready before QA line clearance.