Process Validation Engineer - Marlborough, United Kingdom - Gentell

Description

Process Validation Engineer- £35,000–Marlborough, SN8

The Role

Do you possess experience in the medical device field, including process and test method development? Are you knowledgeable about healthcare regulatory systems? If so, we have an exciting opportunity for you.

We are a global wound care manufacturer, looking to appoint an adept and experienced Process Validation Engineer.

This role is crucial in ensuring our products meet the highest standards of quality and compliance. You will be responsible for a variety of tasks, including equipment validation, process/product validation, and providing technical support.

Ready to advance your career with a leading provider in the healthcare industry? Apply today and become a key contributor to our innovative team.

Key Responsibilities:
New equipment specification, sourcing and validation
Process / product validation
Concept drawings
Technical drawing
Process fault finding and support
Manufacturing Process Record creation
Work instruction generation and training
Technical support
Technical report generation
Project management
Training

Preparation of auditable records of all activities, such as protocols, lab book records, manufacturing paperwork (R&D and Production), Design History Files.

The Company

First Water Ramsbury Limited is part of a larger group of wound care providers supplying wound adhesive dressings and solutions, manufactured for the Healthcare and Industrial markets.

We have a wide-reaching footprint, with manufacturing and operations facilities in Europe, North America and Canada.

The Benefits

Company pension scheme 5% contributions.
Incapacity insurance for a 2 yr period.
Death in Service of 3 x salary.
Company sick pay scheme 4 weeks full pay followed by 4 weeks half pay plus statutory sick pay.
Enhanced maternity benefits.
The Person

Experience in Medical Devices and working within FDA/ISO Quality System Requirements
Excellent communication skills.
Ability to work effectively with all global cultures.
A high level of knowledge of Healthcare regulatory systems.
Commercial awareness.
Excellent IT skills.
Technical programme and project coordination.

Must have experience in the medical device field with process development, test methods development, protocol and report writing, design verification and experience presenting technical concepts.

Must have demonstrated capabilities in developing, writing, and executing design validation protocols and reports.
Demonstrated application of statistical methodologies.
Would consider different Engineering disciplines (mechanical, chemical, biomedical) for the position