Olympus Corporation
Process Validation Engineer
Get notified of more jobs like this · No spam, ever
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
Your Responsibilities
- Implement and work to all applicable regulatory and quality requirements as stipulated within the KeyMed Quality Manual, Quality Policy, and Quality Objectives.
- Implement and work to all applicable Health, Safety and Environmental requirements as stipulated within the HSE Manual, HSE Policies, and HSE Objectives.
- Support project teams and serial production, e.g. Development projects, Continuous Improvement, Change management etc with a focus on process validation.
- Supply advice & direction, compliant to applicable regulatory standards, to stakeholders regarding Process Validation.
- Creation of risk based protocols and review / approval of validation documentation created by other team members.
- Coaching/mentoring/training to increase overall competence and exchange of knowledge.
- Communication and interaction with specialist departments and managers at various international locations.
- Interdisciplinary cooperation with the aim of increasing the efficiency of production, identifying potential for improvement and increasing the quality of engineering activities.
- Application of statistical methods and verification within the validation activities.
- Represent Process Validation during Audits.
- Will undertake any assignment or duty, as required by the business.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
Your Qualification
- Degree (Desirable) or HND or HNC in an engineering discipline with relevant experience (Essential).
- 2+ years working in an engineering or manufacturing environment (Essential).
- Process Validation, specifically FDA Quality System Regulation 21CFR Part 820 and ISO 13485:2016 Medical Devices.
- Process Validation planning, creation of protocols, execution and ongoing maintenance of the validated condition.
- Using DoE and Statistical Analysis to support validation activities.
- Use of ERP Systems, including interrogating, creating and updating data.
- Ability to Interpret Engineering Drawings.
- Computer & IT literacy, familiarity with Office software tools.
- Good written & oral communication skills.
- Ability to work as part of a team.
- Project Management experience.
- Good practical problem solving & analytical skills.
- Methodical & good attention to detail.
- Able to work in a hybrid setting 60% in our Southend office.
Your Competencies
- Patient Focus - We put patients at the heart of everything.
- Integrity - We do the right thing.
- Innovation - We look for new ways to make things better.
- Impact - We take accountability and get things done.
- Empathy - We care for one another and work together.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
Your Benefits
- In addition to a competitive salary, you will receive a generous annual leave entitlement.
- You will be eligible to receive private medical cover.
- Comprehensive company pension scheme.
- You will receive an annual health check with BUPA, funded by us.
- Employee Assistance Program to support your health, mental and emotional-wellbeing.
- At our HQ, we have a subsidised staff restaurant and free parking.
- Other benefits include discounted gym and wellness memberships, cashback and discounts with major UK retailers.
Further Information
We value the diversity of individuals, perspectives, and lifestyles, and prioritise inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.
We warmly encourage all who wish to bring their talents to this role at Olympus, to apply.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London