GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects.
Visual Inspection Engineer Responsibilities: To 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 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.
Execute protocols in a timely basis to meet the project schedule requirements.
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.
Investigate process exceptions or malfunction incidents affecting the process.
To liaise with Internal/External Engineering Personnel and Internal/External Quality personnel as required Support the Production Team in ensuring that manufacturing process is enabled and maintained to meet the output and yield requirements.
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 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.
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