Junior Associate – Production (Downstream)

HypTechie; India; On-site; INR 600,000 - 900,000; Full time

Job summary

HypTechie in India is seeking a dedicated Junior Associate – Production (Downstream) to support GMP-compliant manufacturing operations with real-time documentation, protocol execution, and precise equipment handling.

The role requires strong attention to detail and hands-on experience in downstream operations within a regulated (cGMP) environment. You will maintain regulatory standards and ensure quality across production activities.

Qualifications

• Education: B.Sc. in Life Sciences / Biotechnology / Chemistry (or related field).
• Experience: 4–6 years in production operations, preferably in a regulated (cGMP) environment.

Responsibilities

• Monitor GMP compliance in production areas.
• Adhere to production instructions and procedures.
• Real-time data entry in BMRs, CKL, LS, ECC, and related production documents.
• Execute equipment qualification and validation protocols.
• Document activities in accordance with cGMP standards.
• Coordinate with maintenance for calibration and upkeep.
• Comply with EHS policies and procedures.
• Ensure OTIF execution of downstream (Buffer Preparation) activities.
• Report, evaluate, and document production deviations; investigate critical deviations.
• Support training and development of downstream personnel.
• Prepare, revise, and maintain Batch Manufacturing Records, SOPs, EOPs, Checklists, and Log Sheets.
• Act as data owner for process equipment, ensuring accurate documentation.

Skills

Attention to detail

Real-time documentation

GMP compliance

Data entry

Communication

Education

B.Sc. in Life Sciences / Biotechnology / Chemistry

Job description

Experience: 4 – 6 Years

Education: B.Sc. (Life Sciences / Chemistry / Biotechnology or related discipline)

Role Summary

We are looking for a dedicated Junior Associate – Production (Downstream) to support manufacturing operations in line with Good Manufacturing Practices (GMP) and EHS compliance. The role involves real-time documentation, execution of protocols, equipment handling, and ensuring high-quality, compliant production processes. This position requires strong attention to detail, hands‑on experience in downstream operations, and a proactive approach to maintaining regulatory standards.

Key Responsibilities

• Monitor compliance with Good Manufacturing Practices (GMP) in production areas.
• Ensure strict adherence to production instructions and operational procedures.
• Perform real-time data entry in BMRs, CKL, LS, ECC, and related production documents.
• Execute equipment qualification and validation protocols accurately.
• Carry out and document all activities in accordance with cGMP standards.
• Coordinate with maintenance for equipment calibration and upkeep.
• Comply with all EHS (Environment, Health & Safety) policies and procedures.
• Ensure On-Time-In-Full (OTIF) execution of all downstream (Buffer Preparation) activities.
• Report, evaluate, and document all production deviations; ensure critical deviations are thoroughly investigated.
• Support the training and development of downstream personnel, ensuring continuous compliance.
• Prepare, revise, and maintain Batch Manufacturing Records, SOPs, EOPs, Checklists, and Log Sheets.
• Act as the data owner for process equipment, ensuring accurate and reliable documentation.

Educational Qualifications & Experience

• Education: B.Sc. in Life Sciences / Biotechnology / Chemistry (or related field).
• Experience: 4 – 6 years in production operations, preferably in a regulated (cGMP) environment.