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, Lyophilization, sterilization operations preferable.
• Experience in clean utilities is desirable.

• 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.