Officer - Manufacturing (Drug Product Ampoule Filling)

Why This Role Matters

Ampoule filling is a highly critical aseptic operation in vaccine and biologics manufacturing. Precision in filling volumes, sterility assurance, and contamination control directly impact product quality and patient safety. Even minor deviations can compromise batch integrity.
At Biological E. Limited, the Manufacturing (Drug Product – Ampoule Filling) team ensures sterile filling operations are executed in compliance with cGMP and global regulatory standards.

Job Description

Biological E Limited is hiring experienced professionals for its Manufacturing (Drug Product) department at Shamirpet, Hyderabad. The role focuses on ampoule filling and vial washing operations within sterile manufacturing areas.
The selected candidate will operate and monitor filling lines, maintain aseptic conditions, ensure documentation compliance, and coordinate with QA and Engineering teams for smooth production execution.

Key Features of the Role

• Hands-on exposure to aseptic filling operations
• Work in controlled sterile environments
• Interaction with QA, QC, and Engineering teams
• Opportunity to work with automated filling equipment
• Career growth within vaccine manufacturing operations

Responsibilities

• Execute ampoule filling operations as per SOPs
• Operate and monitor vial washing and filling machines
• Perform line clearance before and after batch operations
• Maintain sterile area discipline and aseptic practices
• Record batch data in Batch Manufacturing Records (BMR)
• Monitor in-process parameters and report deviations
• Coordinate with QA for in-process checks and approvals
• Support media fill activities and validation runs
• Ensure compliance with cGMP and safety guidelines
• Maintain cleanliness and 5S standards in manufacturing area

Required Qualifications

• 2–7 years of experience in sterile manufacturing
• Experience in ampoule filling and vial washing operations
• Knowledge of aseptic techniques and GMP practices

Educational Requirements

• ITI / Diploma
• B.Sc
• Bachelor of Pharmacy

Experience and Skills

• Hands-on experience with ampoule/vial filling lines
• Understanding of sterile area behavior and gowning practices
• Knowledge of contamination control principles
• Familiarity with documentation and batch record entries
• Ability to work in rotational shifts
• Strong attention to detail and compliance mindset
• Good teamwork and coordination skills

Salary Insights

• Competitive compensation based on experience level
• Exposure to advanced sterile filling technologies
• Growth opportunities in Drug Product Manufacturing

Location Details

Department: Manufacturing (Drug Product)
Function: Ampoule Filling
Location: Shamirpet, Hyderabad

Company Overview

Biological E. Limited is a globally recognized vaccine manufacturer known for its high-quality biologics and strong regulatory compliance standards. The company plays a key role in national and international immunization programs.

FAQs

Q: Is sterile manufacturing experience mandatory?
Yes, experience in aseptic or sterile manufacturing environments is required.

Q: Does the role involve shift operations?
Yes, manufacturing operations may require rotational shifts.

Q: Will the role involve validation activities?
Yes, support during media fills and validation batches may be required.

Application Tips

• Mention specific filling machines handled
• Highlight sterile area experience and aseptic practices
• Include details of media fill or validation exposure
• Quantify production targets handled per shift