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Executive

Enzene Biosciences Ltd.
Enzene Biosciences Ltd.
2-5 years
Not Disclosed
Pune, India
10 Feb. 13, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Executive – Fill Finish Operations (Biologics Manufacturing)

Location: Pune, Maharashtra, India

Department: Fill Finish

Employment Type: Permanent (ENZBIO) | Full-Time

Experience Required: 2–5 years in sterile manufacturing / fill finish operations

Job Category: Biopharmaceutical Manufacturing | Aseptic Processing | GMP Operations | Drug Product Manufacturing


Role Overview

We are seeking a skilled Executive – Fill Finish Operations to support sterile drug product manufacturing in a regulated biopharmaceutical environment. The role involves formulation, aseptic filling, equipment handling, and batch execution in compliance with global regulatory standards and Good Manufacturing Practices (GMP).

The ideal candidate will have hands-on experience in vial filling, pre-filled syringe (PFS) operations, cartridge filling, and lyophilization processes, along with strong knowledge of Grade A aseptic handling and data integrity requirements.


Key Responsibilities

  • Perform formulation activities for drug products as per approved manufacturing procedures

  • Execute sterile filling operations for vials, pre-filled syringes (PFS), and cartridges

  • Operate, clean, and maintain filling machines, sealing machines, steam sterilizers, lyophilizers, and associated equipment

  • Execute batch manufacturing activities strictly as per approved Batch Manufacturing Records (BMRs)

  • Perform aseptic operations with strong knowledge of Grade A area handling and interventions

  • Conduct equipment adjustments and troubleshoot breakdowns to ensure uninterrupted production

  • Ensure compliance with Good Manufacturing Practices (GMP), regulatory guidelines, and data integrity principles

  • Identify, report, and support investigation and closure of deviations and non-conformances

  • Maintain and review logbooks, BMRs, SOPs, and manufacturing protocols as per site requirements

  • Ensure accurate, real-time documentation of batch data

  • Work in rotational shifts to support continuous manufacturing operations

  • Support biosimilar manufacturing processes in compliance with global regulatory standards


Required Experience

  • 2–5 years of experience in sterile manufacturing, aseptic processing, or fill finish operations

  • Experience in handling vials, PFS, cartridges, and lyophilized products preferred

  • Practical exposure to GMP-regulated pharmaceutical or biopharmaceutical manufacturing environments

  • Knowledge of deviation handling, documentation practices, and regulatory compliance

  • Experience in biosimilar manufacturing will be an added advantage


Preferred Qualifications

  • Bachelor’s degree or diploma in Pharmacy, Biotechnology, Microbiology, or Life Sciences

  • Strong understanding of aseptic techniques and sterile area operations

  • Familiarity with regulatory expectations for biologics and sterile drug product manufacturing