Description:
We are looking for a Visual Inspection Engineer to join our team in Ballytivan, Sligo. To be successful in this role, you will need to have excellent technical and interpersonal skills and be comfortable communicating with internal and external stakeholders such as Quality, Compliance, and external regulatory bodies such as the FDA (Food and Drug Administration) and HPRA.
Roles And Responsibilities
- Support Visual Inspection operations in line with all safety, regulatory and organisational requirements.
- Develop and modify procedures as required to support the manufacturing operation.
- Provide Technical Input to guide the development of SOPs (Standard Operating Procedure) for Visual Inspection.
- Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements.
- Establish, lead, and improve the process for certification of technicians for visual inspection.
- Establish and run the process for the trending of Visual Inspection Defects.
- Coordinate with internal/external stakeholders for the evaluation of particles/defects.
- Participate and lead (as required) Process FMEAs (Failure Modes and Effects Analysis) for Visual Inspection.
- Investigate process exceptions or malfunction incidents affecting the process.
- Support of technical transfers for future product introductions to the site.
- 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 promptly to meet the project schedule requirements.
- Lead manufacturing and validation activities during project life cycle.
- Liaise with Internal/External Engineering and Quality personnel.
- Support the Production Team in ensuring that manufacturing process is enabled and maintained to meet output and yield requirements.
Qualifications
- Degree in Engineering, Science, or other relevant technical subject(s).
- 3 years experience in a similar role gained in pharmaceutical or medical device manufacturing.
- Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation or sterilisation operations would be advantageous