Executive- Manufacturing (Fill Finish)

Enzene; Chakan; On-site; INR 300,000 - 420,000; Full time

Job summary

Enzene in Maharashtra, India, seeks a hands-on operations specialist to support formulation and filling activities in a sterile manufacturing environment.

You will operate and maintain filling lines for vials, PFS, and cartridges, ensure batch records are accurate, and uphold GMP and aseptic standards.

The role requires 2–5 years of relevant experience and a disciplined approach to documentation and equipment maintenance.

Qualifications

• 2–5 years in handling and executing formulation and filling operations.
• Experience with aseptic operations is preferred.

Responsibilities

• Formulation of drug products.
• Fill drug products in vials, PFS, and cartridges.
• Operate and clean filling machines, sealing machines, steam sterilizers, lyophilizers, and related equipment.
• Execute batch manufacturing operations per batch records.
• Apply aseptic techniques and handle interventions under Grade A.
• Adjust equipment and troubleshoot breakdowns.
• Maintain GMP compliance and awareness.
• Report and manage deviations.
• Maintain logbooks, BMRs, SOPs, and protocols.
• Record batch data in real-time.

Skills

Formulation and filling ops

Aseptic operations

Job description

Role & responsibilities:

1. Formulation: Responsible for the formulation of drug products.

2. Filling: Execute the filling of drug products in vials, PFS (Pre-Filled Syringes), and cartridges.

3. Equipment Operation: Operate and clean filling machines, sealing machines, steam sterilizers, lyophilizers, and other associated equipment.

4. Batch Operations: Execute batch manufacturing operations as per instructions provided in the batch records.

5. Aseptic Operations: Possess sound knowledge and experience in aseptic operations and handling interventions under Grade A.

6. Equipment Handling: Perform adjustments in equipment and handle breakdowns efficiently.

7. GMP Compliance: Maintain a thorough understanding of Good Manufacturing Practices (GMP).

8. Deviation Handling: Report and handle deviations effectively.

9. Documentation: Maintain logbooks, Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and protocols in the facility as per procedures.

10. Batch Data Recording: Ensure real-time recording of batch data in records.

Preferred candidate profile:

• 2 to 5 years in handling and executing formulation and filling operations.