Visual Inspection Engineer
Responsibilities:
1. Work as a team member to support Visual Inspection operations in line with all safety, regulatory, and organizational requirements.
2. Develop and modify procedures as needed to support manufacturing operations.
3. Participate in process, equipment, and facilities validations efforts and project implementations.
4. Review and approve process-related commissioning, qualification, and validation protocols for completeness and accuracy.
5. Execute protocols in a timely manner to meet project schedule requirements.
6. Participate and lead (as required) Process FMEAs (Failure Mode Effects Analysis) for Visual Inspection.
7. Establish, lead, and optimize the process for certification of technicians for visual inspection.
8. Establish and maintain the defect library.
9. Establish and execute the process for trending Visual Inspection defects.
10. Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements.
11. Provide technical input to guide the development of SOPs for Visual Inspection.
12. Lead manufacturing and validation activities during the project lifecycle.
13. Coordinate with internal/external stakeholders for the evaluation of particles/defects.
14. Support technical transfers for future product introductions to the site.
15. Investigate process exceptions or malfunction incidents affecting the process.
16. Liaise with Internal/External Engineering Personnel and Internal/External Quality personnel as required.
17. 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 years of total combined experience in Technical/Operations/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization.
* At least three 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.