At a Glance
- Tasks: Support project teams and ensure compliance with quality and safety standards.
- Company: Join a leading medical device company focused on innovation and patient care.
- Benefits: Enjoy competitive salary, generous leave, private medical cover, and wellness perks.
- Other info: Hybrid work model with opportunities for growth and a supportive team culture.
- Why this job: Make a real impact in healthcare while developing your engineering skills.
- Qualifications: Degree or HND in engineering with 2+ years in manufacturing or engineering.
The predicted salary is between 41220 - 50380 £ per year.
- 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
- 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
- Represent Process Validation during Audits.
- Will undertake any assignment or duty, as required by the business
- 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 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
- 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
- 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.
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Process Validation Engineer in Southend-on-Sea employer: Olympus Corporation
Olympus Corporation is an exceptional employer, offering a dynamic work culture that prioritises employee well-being and professional growth. With competitive salaries, comprehensive benefits like private medical cover and annual health checks, and a commitment to fostering strong stakeholder relationships, employees are empowered to thrive in their roles while making a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Process Validation Engineer in Southend-on-Sea
✨Join Engineering Meetups!
Get yourself along to local engineering meetups or tech conferences. These are great places to connect with like-minded folks and industry leaders who might just have a lead on that full-time Process Validation Engineer role you’re after at Olympus Corporation.
✨Show Off Your Projects!
Don’t be shy about showcasing your engineering projects. Whether it’s a funky app, a mechanical design, or a complex algorithm, having a solid portfolio on platforms like GitHub can really make you stand out. Plus, it gives potential employers at Olympus Corporation a taste of what you can bring to the table!
✨Engage with Online Communities
Dive into engineering forums and online communities, like Reddit or specific engineering Discord channels. Sharing your insights, asking questions, and being active can help you build connections that might lead to job opportunities at Olympus Corporation.
✨Apply Through Company Websites
When you spot a role like Process Validation Engineer at Olympus Corporation, apply directly through their website. Often, this can show your genuine interest in the company and you might just get noticed quicker than via typical job boards.
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.
Focus on Results and Impact:In the engineering world, we love numbers and real-world impact. Quantify your achievements wherever possible—like reducing costs by a certain percentage, improving efficiency, or successfully completing a project ahead of schedule. This gives your future employers at Olympus Corporation a clear picture of the value you can bring.
Craft a Compelling Cover Letter:Use your cover letter to express your passion for engineering and explain why you’re drawn to Olympus Corporation specifically. Share what aspects of their work excite you and how your values align with theirs. This is your chance to show a bit of personality while keeping it professional!
Include Relevant Certifications:If you have any engineering certifications, especially ones that are recognised in your field, make sure to feature them prominently on your CV. They demonstrate not just your knowledge, but also your commitment to professional development, which is something we at StudySmarter value highly.
How to prepare for a job interview at Olympus Corporation
✨Brush Up on Core Engineering Principles
Before heading into the interview with Olympus Corporation, make sure you're solid on the fundamental engineering principles relevant to the role. Be ready to discuss concepts such as thermodynamics, fluid mechanics, or structural analysis, depending on the specifics mentioned in the job description. Don’t skip any hands-on projects or coursework; these can be excellent talking points!
✨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
In a full-time role, employers like Olympus Corporation want to see that you can adapt and grow within their team. Be ready to discuss how your previous internships, projects, or studies relate directly to the work you'll be doing. Highlight specific experiences that showcase your collaborative skills and how you've successfully worked within a team environment.
✨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.
