At a Glance
- Tasks: Ensure all site validation needs are met for medical device production.
- Company: Join a UK manufacturer known for quality and employee care in medical devices.
- Benefits: Enjoy a £45k salary, pension contributions, health plans, and 23 days leave.
- Why this job: Be part of a reputable company making a real impact in healthcare.
- Qualifications: Degree in mechanical or electrical engineering; experience in medical device manufacturing required.
- Other info: Ideal for team players who thrive in dynamic environments.
The predicted salary is between 36000 - 54000 £ per year.
The Company:
- UK manufacturer of single use medical devices
- Global reach
- Outstanding reputation for service and product quality
- Looks after their employees
Benefits of the Validation Engineer:
- £45k basic salary
- Death in Service (2 x Salary)
- Employer Pension @ 5% employer + 5% employee
- 23 Days annual leave + bank holidays
- Health Shield - Employee Health Cash Plan
- Perkbox
The Role of the Validation Engineer:
Our client is a leading medical devices manufacturer. This role is to ensure all site validation needs are met. You will be responsible for validating all production, service provision, computer and software-based processes, the result of which cannot be verified by subsequent monitoring or measurement. Validation must demonstrate the ability of these processes to consistently achieve expected results. The role includes re-validation of established processes as well as initial validation of amended or new processes, such as those introduced through new product development activities.
- Creating Validation Master Plans and associated protocols
- Create or amend standard operating procedures in accordance with the results of the validation
- Creating validation and related working forms
- Supporting site cross-functional technical writing needs
- Maintenance of Sterilisation Validation for both Gamma and Ethylene Oxide processes
- Assist in the implementation of the validation protocols and write the validation reports
- Support cross-functional risk management activities
- Support in the optimization of production processes
- Preparation of plans for maintenance, service, calibration, re-validation and cleaning of test and production equipment
- Policing and coordinating maintenance, service, calibration, re-validation and cleaning
- Advise the business on current best practice in validation and keep abreast of changes
- Contribute to continuous improvement projects
The Ideal Person for the Validation Engineer:
- Must hold a mechanical engineering or electrical engineering degree
- Must have previous experience of medical device or pharmaceutical manufacturing
- Must have practical experience in manufacturing technology and quality assurance
- Must have understanding of Quality Management Systems for medical Devices (EN ISO 13485, 21 CFR 820)
- Experience in validation / qualification
- Experience in Project Work and/or Project Management
- Good to very good knowledge of common MS Office Programs
- Able to adhere to and communicate the company values
- Must have strong communication skills able to communicate with all levels of organisation
- A good team player who is able to adapt to working independently or with new or short-term teams
If you think the role of Validation Engineer is for you, apply now!
Validation Engineer employer: On Target Recruitment
Contact Detail:
On Target Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Engineer
✨Tip Number 1
Familiarise yourself with the specific regulations and standards relevant to medical devices, such as EN ISO 13485 and 21 CFR 820. This knowledge will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who work in validation roles. Attend industry events or join relevant online forums to gain insights and potentially get referrals.
✨Tip Number 3
Prepare to discuss your practical experience in manufacturing technology and quality assurance during interviews. Be ready to provide examples of how you've contributed to validation processes in previous roles.
✨Tip Number 4
Showcase your communication skills by preparing to explain complex validation concepts in simple terms. This will highlight your ability to work cross-functionally and support technical writing needs within the organisation.
We think you need these skills to ace Validation Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical device or pharmaceutical manufacturing. Emphasise your mechanical or electrical engineering degree and any specific validation or qualification experience.
Craft a Strong Cover Letter: Write a cover letter that directly addresses the key responsibilities of the Validation Engineer role. Mention your understanding of Quality Management Systems and how your skills align with the company's needs.
Showcase Communication Skills: In your application, provide examples of how you've effectively communicated with different levels of an organisation. This is crucial for the role, so highlight your teamwork and adaptability.
Highlight Continuous Improvement Experience: If you have been involved in continuous improvement projects, make sure to include this in your application. Detail your contributions and the outcomes to demonstrate your proactive approach.
How to prepare for a job interview at On Target Recruitment
✨Know Your Validation Standards
Familiarise yourself with the relevant standards such as EN ISO 13485 and 21 CFR 820. Being able to discuss these regulations confidently will show your understanding of the industry and its requirements.
✨Demonstrate Your Technical Skills
Prepare to discuss your practical experience in validation and qualification processes. Be ready to provide examples of how you've successfully implemented validation protocols in previous roles.
✨Showcase Your Communication Abilities
As a Validation Engineer, you'll need to communicate effectively across various levels of the organisation. Prepare examples that highlight your ability to convey complex information clearly and work collaboratively with cross-functional teams.
✨Emphasise Continuous Improvement
Be prepared to discuss how you've contributed to continuous improvement projects in the past. Highlight your problem-solving skills and your proactive approach to optimising production processes.