Key Responsibilities

Manufacturing Operations

• Perform dispensing, sifting, mixing, homogenization, emulsification, and manufacturing activities as per approved BMRs and SOPs.
• Operate manufacturing equipment such as mixers, homogenizers, planetary mixers, manufacturing vessels, transfer pumps, and storage tanks.
• Execute batch manufacturing activities within scheduled timelines.
• Monitor and control process parameters such as temperature, mixing speed, pressure, vacuum, and processing time.
• Carry out batch charging and material addition activities as per manufacturing instructions.
• Perform product transfers between manufacturing vessels and holding tanks.
• Support scale-up and technology transfer batches when required.

Equipment Operation & Maintenance

• Perform equipment preparation, assembly, dismantling, and cleaning activities.
• Conduct pre-operation checks and ensure equipment is fit for use before manufacturing.
• Record equipment usage in logbooks.
• Identify equipment abnormalities and report them to supervisors and engineering teams.
• Support preventive maintenance and equipment qualification activities.

GMP & Documentation

• Complete manufacturing records accurately and contemporaneously.
• Maintain BMRs, equipment logbooks, cleaning records, and area checklists.
• Follow Good Documentation Practices (GDP) at all times.
• Report deviations, incidents, and non-conformances immediately.
• Participate in investigations and CAPA implementation activities.

Quality Compliance

• Ensure adherence to current Good Manufacturing Practices (cGMP).
• Follow approved SOPs, specifications, and manufacturing procedures.
• Perform line clearance verification before and after batch activities.
• Ensure no mix-ups, contamination, or cross-contamination occur during production.
• Support QA during in-process checks and audits.
• Maintain batch traceability throughout manufacturing operations.

Cleaning & Hygiene

• Perform cleaning and sanitization of manufacturing equipment and production areas.
• Follow cleaning validation requirements and cleaning procedures.
• Ensure manufacturing areas are maintained in a clean and inspection-ready condition.
• Dispose of waste materials as per approved procedures.

Safety, Health & Environment

• Follow EHS policies and safe work practices.
• Use required PPE during manufacturing activities.
• Report unsafe conditions, near misses, and safety incidents.
• Participate in safety observations, risk assessments, and emergency response activities.
• Handle chemicals, active ingredients, and cleaning agents safely.

Productivity & Continuous Improvement

• Minimize process losses and material wastage.
• Support Lean, Operational Excellence, and Continuous Improvement initiatives.
• Participate in Kaizen, 5S, and productivity improvement projects.
• Contribute ideas to improve process efficiency, quality, and safety.

Audit & Inspection Readiness

• Maintain production areas in a state of audit readiness.
• Support internal, customer, and regulatory audits.
• Demonstrate process and documentation knowledge during inspections.
• Ensure compliance with USFDA, MHRA, EU GMP, WHO GMP, and other applicable regulatory requirements.

Educational Qualification

Essential

• Diploma in Mechanical Engineering, or related discipline.

Experience

3-6 Years