Lyophilization Operator – Injectables

KeyBiz Dashboards Pvt Ltd; Hyderabad; On-site; INR 400,000 - 600,000; Full time

Job summary

A pharmaceutical company in Hyderabad is seeking an experienced candidate to operate and monitor lyophilization equipment. Responsibilities include preparing and loading vials into the lyophilizer, setting critical process parameters, and ensuring compliance with quality standards. Candidates must have a minimum of 2 years of experience in the relevant sector. The role requires knowledge of aseptic techniques and cleanroom protocols, making it vital for maintaining product stability and integrity.

Qualifications

• Minimum 2 years of experience in the relevant sector.

Responsibilities

• Operate and monitor lyophilization equipment as per batch manufacturing records.
• Prepare and load vials or trays into the lyophilizer according to SOPs.
• Set and monitor critical process parameters such as temperature, vacuum, and cycle duration.
• Ensure uniform drying and product stability during lyophilization.
• Perform in-process checks and ensure compliance with quality standards.
• Conduct routine cleaning, sterilization, and preventive maintenance of lyophilization equipment.
• Maintain accurate batch records, logs, and documentation.
• Identify and report any process deviations, equipment malfunctions, or product defects.
• Coordinate with QA/QC for in-process inspections and approvals.
• Follow aseptic techniques and strict cleanroom protocols.

Job description

Responsibilities

• Operate and monitor lyophilization equipment as per batch manufacturing records.
• Prepare and load vials or trays into the lyophilizer according to SOPs.
• Set and monitor critical process parameters such as temperature, vacuum, and cycle duration.
• Ensure uniform drying and product stability during lyophilization.
• Perform in-process checks and ensure compliance with quality standards.
• Conduct routine cleaning, sterilization, and preventive maintenance of lyophilization equipment.
• Maintain accurate batch records, logs, and documentation.
• Identify and report any process deviations, equipment malfunctions, or product defects.
• Coordinate with QA/QC for in-process inspections and approvals.
• Follow aseptic techniques and strict cleanroom protocols.

Qualifications

• Minimum 2 years of experience in the relevant sector.