Manufacturing Support Engineer

Job Responsibilities:

• Ensure compliance to GMP regulation and SOPs.
• Be responsible in the qualification and requalification of the process equipment.
• Be responsible for the daily management of equipment, including equipment acceptance, asset registration form and equipment release.
• Responsible for equipment life cycle management (from commissioning to qualification and decommissioning).
• Participate in the investigation of deviation and variation.
• Drafting/maintaining SOPs and relevant process documents.
• Support change control and audit.
• Any other work assigned by Supervisor.

Qualification

• Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. Biological Engineering, or related field.
• Minimum of 3 years of hands-on experience in biopharmaceutical manufacturing
• Demonstrates a good understanding of cGMP and GDP requirements in a regulated manufacturing environment.
• Exhibits a good quality mindset, with awareness of compliance and documentation requirements.
• Possesses good technical and operational skills to support routine manufacturing activities.
• Demonstrates good communication and coordination skills, enabling effective teamwork and collaboration.
• Proficient in basic use of Microsoft Word, PowerPoint, and Excel for documentation and reporting.
• Demonstrates basic leadership qualities, with the ability to support team activities when required.
• Possesses basic management skills, including task coordination and adherence to operational plans.