Purpose of the role
To introduce and validate new products and processes for a global Life Sciences, manufacturing and engineering company.
Knowledge & Key Skills:
* Knowledge of new product development techniques.
* Knowledge of process validation procedures and techniques, e.g. Process and product FMEA, Ishikawa diagrams, Pareto analysis, parts and process capability studies.
* Able to write Factory Acceptance Tests and validation (IQ, OQ and PQ) documents for new products, processes and equipment.
* Competent with Microsoft Office applications and Minitab knowledge of SAP and advantage.
* Ability to work as a team member or to lead teams towards completion of new product projects.
* Able to read and interpret engineering drawings.
* Able to work under pressure to fixed deadlines.
* Knowledge of workshop and Health & Safety working practices.
* Good interpersonal and communication skills, both written and oral.
Essential Qualifications / Education:
* Formal Engineering Qualification (HNC/HND/Degree) and subsequent experience.
* Any formal training and qualification in Six Sigma techniques would be an advantage.
Essential Previous Experience:
* Validation experience with at least some part from a medical device or Bio-Pharmaceutical Manufacturing Industry.
* Additional experience within a Research and Development / New Product Development environment would be a valuable asset.
* Ability to work using own initiative, prioritising work as appropriate whilst maintaining a cross-functional team approach.
* Able to communicate effectively at all levels both internal and external to the company
* Flexibility to work unpaid overtime as required.
* Full UK driving licence.
* Able to travel in UK, Europe, USA on occasions.
* Introduce new Filtration products by team working with R&D, Marketing and Manufacturing in accordance with the Stage Gate Process.
* Facilitate Line transfers from other company locations
* Manage and execute critical material re-qualification's in line with company procedures
* Provide progress reports as part of Product Engineer projects and organise development and qualification batches
* Write detailed validation protocols for FAT, IQ, OQ, PQ.
* Execute validation protocols as above.
* Collate and provide quality performance data in support of new product introductions, line transfers and material qualifications
* Calculate filter costs.
* Liaise with suppliers of materials and equipment.
* Take part in "focus team meetings" on new products - be prepared to present details from manufacturing.
* Solve problems related to new products by using 6 sigma tools, trend analysis, Design of Experiments, FMEA , process risk assessments etc.
* Control and retention of all Manufacturing Design Documents.
* Lead investigations into non-performance of new products.
* To contribute towards the enhancement of production methods.
* Any other reasonable requests that make use of the job holder's skills, experience and knowledge.
General Health and Safety:
* To follow relevant legal requirements and the Company Health & Safety Policy.
* To keep your work area tidy and free from hazards.
* To make a positive contribution to housekeeping.
* Report and address any safety defects
This is a temp to perm position for the right person and will be based predominantly in Ilfracombe in Devon but there may be some requirement to travel to the Portsmouth office.
Annual Salary between £30k-£40k per year based on experience.
Acorn Recruitment Ltd is acting as an Employment Business in relation to this vacancy.