Visual Inspection Engineer Role
We are seeking a skilled Visual Inspection Engineer to support our operations in line with all safety, regulatory and organizational requirements.
Main Responsibilities:
* Develop and modify procedures as needed to support the manufacturing operation.
* Participate in process, equipment, and facilities validations efforts and projects implementations.
* Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy.
* Participate and lead (as required) Process FMEAs 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 the trending of 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.
* Leadership of manufacturing and validation activities during project life cycle.
* Coordination with internal/external stakeholders for the evaluation of particles/defects Support of technical transfers for future product introductions to the site.
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/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 health care 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.