Visual Inspection Technician / Engineer, Drug Product Operations

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

Responsibilities:

• Support the installation and qualification of new manufacturing equipment, and support assigned equipment packages under supervision.

• Support the execution of visual inspection program and procedures

• Support the visual inspection program (i.e., execute defect kit handling, POD activities, QRA participation, and complete training and qualification/requalification requirements).

• Support training activities and provide assistance to visual inspection staff during validation and batch execution.

• Ensure adherence to quality standards and client requirements when performing fully automatic, semi-automatic, and manual inspection processes.

• Collaborate with Engineering and Maintenance by reporting equipment issues and supporting calibration and validation activities as required.

• Work with MSAT, Validation, Quality, and QC teams to ensure procedures are implemented and personnel are supported during new product introductions.

• Stay informed on relevant global regulatory requirements (FDA, EMA, PIC/S, ICH) for visual inspection and product introduction, and maintain compliance with current Good Manufacturing Practices (cGMP).

• Demonstrate understanding of Quality Management System (QMS) production support systems such as Change Control, Deviation, CAPA, and SAP, and support related activities.

• Interface with clients as needed to support technology transfer and new product introduction (NPI) activities.

• Be accountable for assigned visual inspection tasks and ensure 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 assignments.

• Maintain compliance with training requirements at all times.

Requirements:

• 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