Bukit Batok - Drug Product Manufacturing Technician

Drug Product Manufacturing Technician

Location: 2 Tuas View Drive, Singapore 639059

Job Summary

Execute frontline sterile drug product manufacturing operations, including material management, equipment handling, aseptic operations, process monitoring, visual inspection, packaging and GMP compliance across the entire production workflow, etc.

Responsibilities

• Perform sterile manufacturing processes (materials sterilization, formulation, filling, lyophilization, capping, external washing, visual inspection, packaging) using DP equipment (autoclave, automatic filling line, lyophilizers, etc.) .
• Conduct and support the commissioning, SAT, IQ, OQ, PQ, smoke study, media fill, equipment qualification and validation related work during the facility construction stage.
• Possess mastery of DP equipment principles and familiarity with the production process, enabling independent operation and basic maintenance/ troubleshooting of related equipment.
• Report deviations promptly, assist in deviation investigation and CAPA implementation
• Maintain ALCOA++ compliant documentation by accurately completing batch production records

• Manage material handling (issuance, verification, return) with proper status labelling
• Support environmental monitoring (settle plates/airborne particles sampling) and in-process tests sampling

• Strictly adhere to SOPs and EHS protocols (cleanroom gowning, sanitization procedures)
• Participate in process optimization trials (e.g., lyophilization cycle adjustment) and propose efficiency improvements
• Support client/regulatory audits through live process demonstrations and document retrieval
• Support the revise of relevant operating procedures, batch production records, and related files in accordance with GMP requirements

• Diploma or higher in Pharmaceutical Manufacturing, Pharmaceutical Engineering, Pharmacy, Bioengineering, Biotechnology, Chemical Engineering, Microbiology, or related fields.
• Knowledge of GMP is preferred, with expertise in aseptic production being an advantage.
• Possess a solid foundation in pharmacy and biotechnology, with proficiency in Microsoft Office.
• Strong English language skills and the ability to proactively analyze and solve problems that arise in the workplace.
• Excellent hands-on operational skills, with careful and conscientious equipment operation and timely record-keeping.
• Good communication and expression skills.
• Effective team collaboration, efficient execution, and a strong sense of responsibility.

• Production Skills Training: Helps you quickly meet the technical qualification requirements for your current position.
• GMP Hands-on Training: Media fill qualification, Grade A isolator behaviour
• Equipment Usage Skills Training: Familiarize yourself with the facilities and equipment involved in DP.
• Vocational Training: Become familiar with the characteristics and mechanisms of various biopharmaceutical R&D and production, master the skills of efficiently and reasonably managing time, and enhance your core competitiveness.
• Safety Awareness and Professional Training: The company offers a comprehensive system of safety training materials and experienced instructors.
• Monthly Academic Reports: World-renowned scientists and experts are invited to deliver lectures.
• Management Skills Training: Provided by company executives and renowned training institutions to improve employees' practical and theoretical knowledge.