At a Glance
- Tasks: Lead process validation in a dynamic manufacturing environment for medical devices.
- Company: Join a global leader in medical technology with over 100 years of innovation.
- Benefits: Enjoy competitive salary, private medical cover, and generous annual leave.
- Other info: Hybrid work model with a focus on teamwork and continuous improvement.
- Why this job: Make a real impact on healthcare while developing your engineering skills.
- Qualifications: Degree or HND in engineering with 2+ years in manufacturing or engineering.
The predicted salary is between 37800 - 46200 £ per year.
Process Validation Engineer
Key Med (Medical & Industrial Equipment) Ltd. (OKM) | Chief Manufacturing and Supply Officer
A global leader in the medical device and technology industry, for more than 100 years Olympus has focused on making people's lives healthier, safer, and more fulfilling.
Our products and solutions help to diagnose, prevent, and treat illnesses, further scientific research and keep people safe.
Working in the Engineering team within the Manufacturing organisation as the Process Validation Subject Matter Expert (SME).
This position will involve undertaking all aspects of Process Validation in the manufacturing environment, ensuring processes are validated for production use in accordance with relevant regulatory standards.
This role will be responsible for the Site Master Validation Plan, including planning, creation of risk based protocols & reports and executing specific validation activities as well as supporting / moderating validation activities carried out by other Engineers.
The SME will also be responsible for continuously developing the competence within the manufacturing operation and will deliver training when required.
- Key Performance Areas
- Continuous Regulatory Compliance of Process Validation
- Compliance with Health & Safety & Environmental procedures
- Successful completion of mandatory training
- Your responsibilities
- Shall implement and work to all applicable regulatory and quality requirements as stipulated within the Key Med Quality Manual, Quality Policy, and Quality Objectives.
- Shall 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
- Will undertake any assignment or duty, as required by the business
- 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 Do E 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
- Ability to work as part of a team
- Good practical problem solving & analytical skills
- Methodical & good attention to detail
- Able to work in a hybrid setting 60% in our Southend office
- 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
- 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
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.
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Process Validation Engineer in Southend-on-Sea employer: OLYMPUS EUROPA SE & CO. KG
KeyMed (Medical & Industrial Equipment) Ltd. is an exceptional employer, offering a dynamic work environment in the heart of West Sussex, Hampshire, Berkshire, Cheltenham, and Gloucestershire. With a strong focus on patient care and employee well-being, we provide comprehensive benefits including private medical cover, a generous pension scheme, and wellness programmes, all while fostering a culture of integrity, innovation, and empathy. Our commitment to diversity and inclusion ensures that every team member feels valued and empowered to grow within their role.
Contact Details:
OLYMPUS EUROPA SE & CO. KG Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Process Validation Engineer in Southend-on-Sea
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We think you need these skills to ace Process Validation Engineer in Southend-on-Sea
Some tips for your application 🫡
Showcase Your Technical Expertise:When applying for an engineering role like Process Validation Engineer, it’s essential to highlight your technical skills. Include any relevant software or tools you're proficient in on your CV—think CAD software, simulation tools, or programming languages. Don't skimp on any engineering projects you've worked on that demonstrate your ability to solve complex problems.
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How to prepare for a job interview at OLYMPUS EUROPA SE & CO. KG
✨Brush Up on Core Engineering Principles
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✨Show Off Your Problem-Solving Skills
Expect technical questions or case studies during your interview—after all, engineering is all about solving problems! Prepare a few examples of how you've tackled engineering challenges in the past, whether at university or in any practical experience. Practising with mock technical interviews can really help you articulate your thought process and solutions.
✨Relate Your Experience to the Role
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✨Know Your Tools and Software
Most engineering roles require familiarity with specific tools and software. Prepare to talk about your proficiency with programmes like AutoCAD, MATLAB, or SolidWorks if they’re relevant to the role. Even better, have examples of projects where you’ve used these tools, as it'll demonstrate your hands-on experience and readiness for the job.
