NPI Process Engineer

BBI Group
Cardiff (Caerdydd)
03 Oct 2017
02 Nov 2017
Contract Type
Full Time
NPI Process Engineer

Cardiff CF14 5DX/ Crumlin NP11 3EF


BBI Solutions is a leading expert in immunoassay development and manufacturing services, and provides an extensive portfolio of products and technologies to the global diagnostic and pharmaceutical markets.

As a business, we are currently progressing through a substantial period of growth, and currently have the exciting opportunity for an NPI Process Engineer, to join our growing operation. This role will initially be based from our Cardiff site, but will move to our brand new Global Centre of Excellence in Crumlin, by early 2018.

The Role

As the NPI Engineer you will be involved in new product introductions within BBI Solutions Cardiff. This will involve working cross-functionally to support the transition of new products from design concept through to routine production.

Your key responsibilities will include, but not be limited to the following:

Supporting R&D in the design and development of suitable manufacturing and/ or QC processes for transfer to Operations teamsGenerating process documentation, including process FMEAs, Bills of Materials, transfer to production plans, pilot batch protocols and reports.Assisting the co-ordination of pilot batch activities and ensuring appropriate training plans are in place.Supporting Capex and defining tool specificationsExecuting validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives. Support the preparation of Validation Master Plans, Summary Reports and other required documentation for a validation exercise.Ensuring project work is carried out in compliance with regulatory and company requirements. Providing validation support and advice to other areas of the business as required.Ensuring good communication with the team and other departments and Sites as appropriate.Meet agreed targets for project completion as defined by each project planThe Person

As the NPI Engineer you will need to be trained in both design control and risk management, with experience in the following:

ISO13485 and manufacture of medical devices.Technology and/ or design transferContributing to regulatory documents development and/or experience in reading regulatory documentsIt is desirable that you hold a Six Sigma DMAIC Green Belt Certification.

You will also be required to demonstrate previous experience in at least three of the following areas: process development; design/ technology transfer; Bill of Materials; process FMEA; process, cleaning, analytical method, or computer system validation; equipment qualification; generating manufacturing or QC SOPs.

The Package

The salary offering for this role is competitive and makes up part of BBI’s attractive benefits package, which includes:

5% contributory pension scheme.Life AssurancePrivate health care scheme. 28 days’ holidays (inclusive of bank holidays) with up to 4 additional days off, including 1 day for your birthdayParticipation in the childcare voucher and cycle to work schemes.The Company

BBI is a fast-paced and agile business, with a track record of growth, and the opportunity to influence and direct the business going forward. We deliver exceptional products and technologies that people rely on to enjoy a better quality of life. We look for our people to be active participants in BBI life, to make work fun as well as challenging.

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