Production Specialist (2027 Intake, Entry Level)

WUXI BIOLOGICS BIOPHARMACEUTICALS SINGAPORE PRIVATE LIMITED; Singapore; Sur place; SGD 42 000 - 66 000; Plein temps

Résumé du poste

Wuxi Biologics Singapore is seeking a Production Specialist to support the startup of a state-of-the-art aseptic drug product manufacturing facility. You will serve as an end-user for equipment, facility, supporting systems, and utilities in preparation for aseptic operations.

The role includes developing SOPs, master batch records, and work instructions, and collaborating with Engineering, Maintenance, and Validation to ensure timely calibration and validation of production equipment.

Qualifications

• Bachelor's degree in Pharmaceutical Engineering, Chemical Engineering, Biochemical Engineering, Biotechnology or related disciplines.
• Internship/industrial training or project experience in pharmaceutical manufacturing or biotech is an advantage.
• Fresh graduates are welcome to apply.

Responsabilités

• Support the startup and operation of aseptic DP manufacturing lines.
• Assist in developing and implementing SOPs, master batch records, and work instructions.
• Oversee equipment installation, qualification, calibration, and validation with Engineering/maintenance teams.
• Ensure adherence to GMP and quality standards, and to client requirements.
• Coordinate with facilities to maintain compliant manufacturing environments and utilities.
• Be flexible for off-hours and potential shift rotations; participate in overseas training if needed.

Connaissances

SOP Execution

Manufacturing floor operations

Cross-functional collaboration

Formation

Bachelor's degree in Pharmaceutical Engineering / Chemical/Biochemical Engineering / Biotechnology / Biochemistry

Description du poste

Production Specialist, Drug Product Manufacturing Operation

Overview

The Production Specialist will play a critical role in supporting the startup of a state-of-the-art aseptic manufacturing facility for Drug Product (DP) with multiple production lines. Reporting to Supervisor of Commercial DP, this position will serve as an end-user, including its equipment, facility, supporting systems, and utilities, in preparation for aseptic manufacturing operations.

Note: Shuttles to the site are available at some major MRT stations, including east coast and central area.

Key Responsibilities

Responsibilities include supporting developing standard operating procedures (SOPs). The Production specialist will ensure smooth day-to-day operations on the manufacturing floor, with a strong focus on compliant execution of critical aseptic processes.

• Support the installation and qualification of new manufacturing equipment, and own/oversee assigned equipment packages.
• Support the development and implementation of operational procedures, including SOPs, master batch records, and work instructions.
• Ensure adherence to quality standards and client requirement
• Collaborate with Engineering, Maintenance, and Validation to ensure timely calibration and validation of production equipment.
• Maintain manufacturing facilities and ensure adherence to stringent requirements.
• Be flexible for the execution during off-hours and work in a shift rotation, if needed.
• Maintain compliance with training requirements at all times.
• Travel as necessary and be available for extended periods of overseas training.

Requirement

• Bachelor's degree in Pharmaceutical Engineer, Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or related disciplines
• Internship, industrial training, final-year project, or research experience in pharmaceutical manufacturing, biotechnology, or a related industry is an advantage.
• Fresh graduates are welcome to apply
• Overseas training opportunities is available for eligible candidates
• This role may require shift work and support for manufacturing operations in a GMP environment