Visual Inspection Engineer
- Ireland, West
- Contract
- Life Sciences
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Visual Inspection Engineer to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow.
Essential duties and responsibilities for this role include, but are not limited to, the following:
- 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.
- A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)
- Requires extensive total combined experience in Technical/Operations/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organisation.
- Extensive 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.
#LI-CO1
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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