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Date: Nov 11, 2025

Location: Johor bahru, MY

Company: bioconbiolP2

Company Overview

Role Purpose

Team Member-MFG-DP(Fill Finish)-Aseptic Manufacturing-Component prep and sterilization: Focuses on the design, operation, and maintenance of process equipment used in manufacturing. This role involves ensuring that all equipment operates efficiently and meets quality and regulatory standards. Responsibilities include troubleshooting mechanical issues, optimizing equipment performance, and collaborating with other engineering teams to support process improvements. Expertise in process equipment and strong problem-solving skills are essential for maintaining reliable and effective manufacturing operations.

Academic Stream

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Work experience (in months)

0

Job Responsibility and key Decisions

Acquainted with current Good Manufacturing Practice, pharmacopeia, different regulatory requirements and drug and cosmetic acts.

Basic knowledge of microbiology, pharmaceutics, pharmaceutical chemistry, Biotechnology, Data Integrity, ALCOA and other related pharmaceutical subjects.

Ensure quality of drug product at difference stages.

Always ensure data integrity and compliance to quality and regulatory requirements.

Advanced data analysis comfort with change, adaptability, and continuous learning and critical thinking and decision making.

To coordinate with compliance team and QAQMS for documents i.e. change controls, CAPA, Deviations, QRA, Technical document, Study Protocols and reports.

Handling of Internal audits and external audits, and to coordinate for department audits.

Ensure control on microbial contamination in manufacturing area by effective cleanliness of equipmentarea and following aseptic practices.

Ensuring documents availability for batch activity and its online documentation.

Following of aseptic techniques, gowning procedures and carry out aseptic area operations with good aseptic area behaviour.

To involve in media filling, qualifications and validations in coordination with cross functional teams.

Ensure that manufacturing area activities i.e., batch manufacturing, vial washing, filling aseptic area entry exit, autoclave unloading, CIP, SIP, filtration, filling, lyophilizer loading unloading are carried out in compliance with the cGMP requirements, SOPs and BMRs.

Maintain the change parts, spares which are required for all the equipment of aseptic areas.

Ensuring operation and cleaning of autoclaves, vial washing machine, Depyrogenation tunnel, Filling sealing, Lyophilizer, Manufacturing vessels, Manufacturing vessels, Filter integrity machine etc. as per respective SOPs.

Ensure PMP and qualification of these machines in coordination with validation team and ensure activities are performed as per set validated parameters for the equipments.