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