Production Specialist

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.

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.

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

Key Responsibilities

• 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