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.
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 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.
- May provide cross training and guidance to new department members.
- May supervise and lead projects and develop training.
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