Visual Inspections Engineer

Visual Inspections Engineer

Team Horizon is seeking a Visual Inspections Engineer for a Visual Inspections Engineer. This person will be responsible for supporting strategy to qualify samples /streamlining processes and taking part in threshold studies.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  
  
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  
  
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
  
  What you will be doing:
  
  
• 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.
  
  
• May be required to support Cross functional teams and cost improvement projects.
  
  
• Provide technical leadership to functional areas and collaborates with key stakeholders.
  
  
• Leads the delivery of new training initiatives
  
  What you need to apply:
  
  
• 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.
  
  
• Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
  
  
• Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders