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Visual Inspection Engineer

Our client a leader in the Pharmaceutical Industry are seeking a Visual Inspection Engineer to join their Sligo team on a 12 month contract .

Responsibilities:

  • To work as a team member to support Visual Inspection operations in line with all safety, regulatory and organisational 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 optimise 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 Organisation.

  • 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.

For a confidential discussion and more information on the role, please contact Emma Daly.

emma.daly@collinsmcnicholas.ie

0861041202