Process Validation Engineer

RFT Technical Limited
Knutsford, UK
13 Sep 2019
07 Oct 2019
Contract Type
Full Time
Process Validation Engineer - Process Engineer - Validation Engineer - Manufacturing Engineer - Equipment Validation Engineer - Equipment Validation Specialist - Process Development Engineer - Qualification Engineer - Medical Device Manufacturing - ISO13485 - IQ - OQ - PQ - NC - FAT - SAT - CAPA - Process Validation - Process Development - R&D - Machine optimisation - FDA

Location - North West

An exciting opportunity has arisen to join a dynamic, independent developer and manufacturer of innovative and technologically advanced medical device products. To support continued business growth, my client is now looking to recruit a Process Validation Engineer.

The role will support both R&D projects and Operations optimisation and validation work. This role will be responsible for the optimal technical performance of the manufacturing process including maintaining optimal standard processes, delivering continuous improvement within the process and delivering process outputs in line with business objectives.

Key Accountabilities :

* Optimisation of the technical performance for manufacturing processes.

* Establish & maintain standard processes within the validated process window delivering outputs in line with the business objectives on safety, quality, delivery and cost.

* Improve the manufacturing process via capability enhancement & process development.

* Ensure equipment and processes are validated to plan and in compliance with the relevant medical device regulations.

* Develop best in class processes for machine and process validation.

* Responsible for training the engineering team and technical operators in machine and process validation procedures where they become competent in carrying out and documenting all validations assigned to them

Required Knowledge and skills :

* Experience in process / manufacturing engineering or process validation, specifically within converting and/or packaging processes in the medical device industry.

* Excellent leadership, influencing, analytical and communication skills

* Knowledge of IQ/OQ/PQ processes & relevant report writing

* Decision making within framework of company, ISO and FDA standards

* Experience in leading projects in the respect of quality, time, cost, communication

* Ability to analyse business needs and make recommendations based on sound business knowledge and commercial acumen

* Have a pragmatic approach whilst working within a team and autonomously

* Strong working knowledge of Microsoft Office software Word, Excel, Powerpoint & Min-Tab. Working knowledge of AutoCAD and/or SolidWorks.

* Knowledge and experience of plant and machine related health & safety / regulatory compliance requirements

* Degree / HNC qualified in Mechanical, Biomedical, Industrial, or Manufacturing Engineering.

Please get in touch as soon as possible as demand for the role is high.

Kind Regards

Antony Harding

RFT Technical Ltd

(phone number removed)

(phone number removed)

RFT Technical Limited acts as an Employment Agency (perm) and as an Employment Business (contract).

Key Words: - Medical Device Manufacturing - ISO13485 - Medical Device - IQ - OQ - PQ - NC - FAT - SAT - CAPA - Process Validation - Process Development - R&D - Machine optimisation

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