Position: Aseptic Manufacturing & Validation Specialist

Location: Noida

Department: Production / Quality Control

Experience: 8 -10 years

Employment Type: Full-time

Role Overview:

We are seeking a highly skilled Aseptic Manufacturing & Validation Specialist to oversee sterile vial

filling, lyophilization, packaging validation, and contamination control. This role will also be

responsible for identifying and collaborating with vendors to procure and implement automated

aseptic filling lines, ensuring a smooth transition to an automated process. The ideal candidate

should have expertise in cleanroom technology, regulatory compliance and process validation.

Key Responsibilities:

• Execute and monitor aseptic filling operations, including sterile vial filling, lyophilization,

and capping.

• Ensure contamination control in cleanroom environments, adhering to strict aseptic

processing guidelines.

• Lead efforts to identify, evaluate, and coordinate with vendors for procuring automated

aseptic filling lines.

• Oversee the installation, qualification, and validation of new automated equipment and

ensure its seamless integration into manufacturing.

• Perform vial integrity testing, packaging validation, and sealing to maintain sterility

assurance.

• Conduct risk assessments and ensure compliance with global regulatory standards (GMP,

US FDA, EU EMA).

• Troubleshoot aseptic processing and equipment-related issues to optimize sterile

manufacturing.

• Maintain thorough documentation and reports for validation and regulatory audits.

Preferred Qualifications:

• Bachelor’s/Master’s degree in Biotechnology, Microbiology, Pharmaceuticals, or a related

field.

• Hands-on experience in aseptic processing, sterile injectables, and contamination control.

• Strong knowledge of GMP, US FDA, and EU EMA regulatory guidelines.

• Prior experience in vendor coordination, equipment procurement, and process automation.