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 manner 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 the 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/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, is 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
