Visual Inspection Engineer
Responsibilities:
- Work as a team member to support Visual Inspection operations in line with all safety, regulatory, and organizational requirements.
- Develop and modify procedures as needed to support manufacturing operations.
- Participate in process, equipment, and facilities validations efforts and project implementations.
- Review and approve process-related commissioning, qualification, and validation protocols for completeness and accuracy.
- Execute protocols in a timely manner to meet project schedule requirements.
- Participate and lead (as required) Process FMEAs (Failure Mode Effects Analysis) for Visual Inspection.
- Establish, lead, and optimize the process for certification of technicians for visual inspection.
- Establish and maintain the defect library.
- Establish and execute the process for trending Visual Inspection defects.
- Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements.
- Provide technical input to guide the development of SOPs for Visual Inspection.
- Lead manufacturing and validation activities during the project lifecycle.
- Coordinate with internal/external stakeholders for the evaluation of particles/defects.
- Support technical transfers for future product introductions to the site.
- Investigate process exceptions or malfunction incidents affecting the process.
- Liaise with Internal/External Engineering Personnel and Internal/External Quality personnel as required.
- Support the Production Team in ensuring that the manufacturing process is enabled and maintained to meet the output and yield requirements.
Essential Requirements:
- A relevant third-level qualification in an engineering, science, or technical discipline (Degree Level or Masters Preferable).
- At least three (3) years of total combined experience in Technical/Operations/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization.
- At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical, or healthcare plant.
- Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill-finish, lyophilisation, sterilisation operations preferable.
- Experience in clean utilities is desirable.
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