Visual Inspection Engineer & Technician (MVI/AVI, NPI)

Wuxi Biologics Biopharmaceuticals Singapore Private Limited; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Wuxi Biologics Biopharmaceuticals Singapore Private Limited seeks a hands-on professional to support the visual inspection manufacturing process. You will assist installation, qualification, and operation of MVI/AVI systems while ensuring compliance with cGMP and client requirements.

You will collaborate with Engineering, Maintenance, QA, QC, and MSAT teams, participate in audits, and stay updated on FDA/EMA guidelines relevant to visual inspection and product introduction.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering or related field.
• 3+ years of experience in drug product manufacturing, with experience in visual inspection.
• Direct experience in drug product manufacturing, particularly in building and managing visual inspection process (MVI/AVI) and program.
• Direct experience with client and regulatory audits is a plus.

Responsibilities

• Support installation and qualification of new manufacturing equipment under supervision.
• Support execution of visual inspection program and procedures.
• Execute defect kit handling, POD activities, QRA participation, and training/qualification.
• Assist training activities and support staff during validation and batch execution.
• Ensure adherence to quality standards and client requirements during inspection processes.
• Collaborate with Engineering and Maintenance to report equipment issues and support calibration/validation.
• Work with MSAT, Validation, Quality, and QC to implement procedures and support personnel during NPI.
• Stay informed on global regulatory requirements (FDA, EMA, PIC/S, ICH) for visual inspection and product introduction.
• Maintain compliance with cGMP.
• Demonstrate understanding of QMS production support systems such as Change Control, Deviation, CAPA, SAP.
• Support related activities.
• Interface with clients to support technology transfer and NPI.
• Be accountable for assigned visual inspection tasks and adherence to stringent requirements.
• Be flexible to support execution during off-hours if needed.
• Some travel may be required for project support, site visits, or overseas training.
• Maintain compliance with training requirements at all times.

Skills

Visual inspection

Quality assurance

Education

Bachelor's degree in Pharmaceutical Sciences or Chemical Engineering

Job description

Wuxi Biologics Biopharmaceuticals Singapore Private Limited seeks a hands-on professional to support the visual inspection manufacturing process. You will assist installation, qualification, and operation of MVI/AVI systems while ensuring compliance with cGMP and client requirements.

You will collaborate with Engineering, Maintenance, QA, QC, and MSAT teams, participate in audits, and stay updated on FDA/EMA guidelines relevant to visual inspection and product introduction.