Visual Inspection Engineer

2 weeks ago

Sligo, Sligo, Ireland DPS Group Global Full time

Arcadis DPS are recruiting a Visual Inspection Engineer for a leading pharmaceutical company in Sligo.

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
  • 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.

Interested parties should forward a copy of their CV through the link below

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