Project Engineer

Job Title; Project Engineer - 6 month Contract Company; CytivaLocation; Ilfracombe, North DevonContract Type; 6 Month ContractHours; Full-time, Monday - Thursday 8.00am - 16.30pm / Friday 8.00am - 15.30pm

Acorn by Synergie is proudly working in partnership with Cytiva recruiting Project Engineer for the Life Sciences site in Ilfracombe, North Devon on 6 month contract.If you have an Engineering qualification (HNC/HND/Degree) and subsequent Experience please Read on.

The purpose of the position is to engineer and validate new tooling and processes for Cytiva. The job holder will be required to develop existing tooling and equipment, write a series of validation documents which should be robust against external audits and fully implement to production. The documents should be written in accordance with Cytiva procedures and be sufficient to support any future transfer of the product to other sites within Cytiva.

MAIN DUTIES:

• Complete work packages to improve process and equipment performance in line with detailed plan.
• 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 process improvements
• 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

POSITION COMPETENCIES:

• Knowledge & Key Skills:
• Knowledge of tool and equipment design.
• Knowledge of polymer welding technology.
• 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:

• Machine and tooling design.
• 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.

Miscellaneous:

• 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 Pall.
• Flexibility to work unpaid overtime as required.
• Full UK driving licence.
• Able to travel in UK, Europe, USA on occasions.

Please contact or for more information