Validation Engineer

Overview

Do you have validation engineering experience within the Med Tech industry? Are you interested in making an impact on patients’ lives? If so, we want to hear from you!

Amber Therapeutics are looking for a Validation Engineer to join our growing team to contribute to the design, development and validation of active implantable medical device products. This is an onsite role, based at our facility at Harwell Science & Innovation Campus, Oxfordshire. Amber is a pioneering neuromodulation company dedicated to transforming the lives of patients through advanced medical technology.

As a Validation Engineer, you will play a key role in bringing life-changing active implantable medical devices to market. You will lead the planning, execution and reporting of validation activities across production processes, manufacturing and test equipment, working at the heart of a collaborative, high-performing team. This role offers the opportunity to optimise and shape production and test processes, contribute to equipment development, drive continuous improvement and uphold the highest quality and regulatory standards within a highly regulated, innovative environment.

• Develop, execute and maintain validation and revalidation plans.
• Create and maintain validation processes and procedures in line with regulatory requirements.
• Manage and deliver validation-related projects.
• Collaborate with Quality Assurance, Product Development and Procurement to resolve issues and optimise resources.
• Investigate and resolve process inefficiencies, equipment failures and quality deviations using best-practice problem-solving (e.g. Six Sigma).
• Maintain, test and improve equipment and processes based on performance and test outcomes.
• Ensure compliance with safety legislation, environmental standards and regulatory requirements, mitigating risk where required.
• Maintain accurate validation, process and QMS documentation, databases and records.
• Ensure ongoing compliance of utilities and equipment with approved procedures and regulations.
• Contribute to risk management activities and continuous improvement initiatives.

• Degree qualification or higher in technical engineering or science discipline
• Validation experience in Med Tech industry or similar (e.g. Med Tech, Pharma)
• Familiarity with quality systems e.g. ISO
  13485 or FDA QSR
• Experience in the development and execution of validation protocols & reports including associated test method validations is essential
• Participation in risk management activities (e.g. PFMEA or DFMEA) and experience with the impact of risk management on validation strategies essential
• Six Sigma Green Belt or similar is advantageous

The successful candidate should have proven experience of validation activities in a highly regulated environment (ideally Med Tech or related) and strong project management skills. With the ability to work effectively both within a team and independently, you will have excellent interpersonal and communication skills, and thrive in a fast-paced, multi-disciplinary environment.

Amber Therapeutics is developing a closed-loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcome of a very large untreated patient population. Amber’s fully implantable Picostim

TM System targets the pudendal nerve with a device that can both stimulate and sense physiological responses. Please refer to our website for further information.

This is a chance to be part of a ground-breaking team creating life-changing therapies for millions of people globally. You join us at an exciting phase of our development, as we expand the team and accelerate towards our first Pivotal Trial. In addition, we offer a competitive salary commensurate with experience, private healthcare, income protection, life assurance, company pension scheme and 27 days holiday (plus bank holidays).

Amber Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We look forward to hearing from you.

Benefits:
Private healthcare, pension, income protection, life assurance, 27 days holiday + bank holidays, equity scheme