Unique Biotech Limited is seeking a proactive and skilled Production Executive to join our sterile manufacturing unit in Hyderabad. The ideal candidate will be responsible for executing end-to-end sterile manufacturing operations, managing aseptic processes, and ensuring strict adherence to cGMP and global regulatory guidelines (USFDA / EU).

Roles & Responsibilities

- Sterile Operations: Execute daily sterile manufacturing activities in compliance with approved SOPs, Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and safety guidelines.
- CIP & SIP Management: Perform and monitor Clean-in-Place (CIP) and Sterilization-in-Place (SIP) routines for mixing and manufacturing vessels.
- Autoclave & Equipment Operation: Operate steam sterilizers/autoclaves for equipment and component sterilization; perform line clearance and verify equipment readiness prior to batches.
- Aseptic Filling Line: Supervise and operate sterile filling line operations, maintaining strict aseptic setting controls and parameter monitoring.
- Process & Batch Preparation:



Handle drug product preparation and compounding according to defined batch production procedures.
- Compliance & Documentation: Maintain precise, real-time BMR/BPR documentation, ensuring 100% data integrity and cGMP compliance.
- Deviations & Audits: Report process abnormalities, assist in root-cause investigations, and actively support internal, USFDA, and EU regulatory audits.

Desired Candidate Profile

- Experience: 2 to 4 years of hands-on experience in sterile pharmaceutical or biotech manufacturing.
- Technical Expertise: Proven competency in CIP/SIP, autoclaves, sterile filling lines, and aseptic processing techniques.
- Audit Exposure: Familiarity with regulatory audit standards (USFDA, EU GMP, WHO) is highly desirable.
- Skills: Strong documentation practices, analytical troubleshooting, and effective cross-functional communication.

Education: B.Pharm, B.Tech/B.E. in Biotechnology, B.Sc/M.Sc in Microbiology, Chemistry, or relevant Life Sciences

📌 Production Executive - Sterile Manufacturing (Hyderabad)
🏢 Unique Biotech
📍 Hyderabad