Visual Inspection Engineer
Ballytivnan, Ireland
Who We are:
NIRAS Ireland specializes in design and delivery of process-driven and high end life science projects. We provide Project Management, Engineering Design, Project and Managed Service resources to the advanced Process Manufacturing, Life Science, Food & Beverage sectors across Ireland and internationally. One of Europe's largest development consulting firms. NIRAS employs over 3000 permanent staff and has a pool of 25,000+ experts across our network. With 51 offices in 32 countries. A value-driven, multi-disciplinary engineering consultancy, NIRAS is fundamentally committed to sustainable progress and service delivery. At NIRAS you can grow! Come join us.
Position Opportunity:
NIRAS Ireland are currently recruiting a Visual Inspection Engineer where the successful candidate will be responsible for supporting our clients strategy to qualify samples /streamline processes and take part in threshold studies. The selected candidate will join our client on site team at their advanced technology manufacturing facility based in the beautiful North West of Ireland. This is a 12 month contract with the selected candidate reporting directly to the Operations Lead.
Role Description
* To work as a team member to support Visual Inspection operations in line with all safety, regulatory and organizational requirements.
* Leadership of manufacturing and validation activities during project life cycle.
* Participate in process, equipment, and facilities validations efforts and projects implementations.
* Develop and modify procedures as needed to support the manufacturing operation.
* Review and approve process commissioning, qualification and validation protocols for completeness and accuracy.
* Participate and lead (as required) Process FMEAs for Visual Inspection
* Execute protocols in a timely basis to meet project schedule requirements.
* 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 development of SOPs for Visual Inspection.
* 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 Production Team in ensuring manufacturing process is enabled and maintained to meet output and yield requirements.
Experience and Qualification Requirements
* Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.
* A Third level qualification in engineering, science or technical discipline (Degree Level or Masters Preferable)
* 3+ years total combined experience in Technical/Operations/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization.
* 3+ years of experience in manufacturing environment of a biotechnology, pharmaceutical or health care plant.
* Experience in clean utilities is desirable.
* Travel will be involved in this role for training/collaboration.
* Preferred candidates will need 3+ years+ experience in MVI of vials or syringes and extensive knowledge of processes and USP 1790.
* Consideration will begiven to candidates coming from Drug Product/Sterile manufacturing.
What to Do next
For a confidential discussion regarding this and our many other exciting opportunities with NIRAS Ireland, please contact Philip Cahill at 00353 482 2270 /00353 87 997 9941 or email your cv to phic@niras.com
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