Our client, a leader in the Pharmaceutical Industry is seeking a Visual Inspection Engineer (Manufacturing Engineer) to join their Sligo Team.
12 Month FTC initially.
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 project 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.
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 the 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/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.
For a confidential discussion and more information on the role, please contact Emma Daly.
emma.daly@collinsmcnicholas.ie
0861041202
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