At a Glance
- Tasks: Manage customer validation projects and ensure compliance with international standards.
- Company: Sotera Health, a leader in global healthcare safety and quality.
- Benefits: 34 days holiday, health plan, pension scheme, and life assurance.
- Other info: Join a dynamic team with opportunities for professional growth.
- Why this job: Make a real impact in healthcare by ensuring the safety of medical devices.
- Qualifications: Experience in regulated industries and strong analytical skills required.
The predicted salary is between 29700 - 36300 £ per year.
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.
We are currently seeking a Validation Engineer to join our Quality team at our Somercotes facility on a 12-month fixed-term contract. This role offers an exciting opportunity to work in a highly regulated environment, supporting customer validation projects, maintaining compliance with international standards, and contributing to continuous improvement initiatives.
About the Role
Reporting to the Quality Assurance Manager, the Validation Engineer serves as the facility's technical representative for validation activities, ensuring compliance with ISO standards, FDA regulations and customer requirements. You will work across multiple functions including Operations, Engineering, Sales, Quality and external customers to successfully plan, execute and document validation programmes.
Key Responsibilities
- Plan, coordinate and manage customer validation projects from initiation through to completion.
- Write validation protocols, reports and supporting technical documentation.
- Review customer-supplied validation protocols to ensure compliance and operational feasibility.
- Execute validation studies, including scheduling processing runs, laboratory testing and sample management activities.
- Collect, analyse and interpret validation data.
- Support equipment qualification activities, including IQ, OQ and PQ protocols.
- Ensure calibration activities are performed in accordance with the Sterigenics Quality Management System and relevant standards.
- Maintain accurate and compliant validation records and documentation.
- Lead improvement projects to enhance efficiency and reduce process deficiencies.
- Act as a technical contact for customers and internal stakeholders on validation-related matters.
About You
Essential Requirements
- Experience working within a regulated industry such as Medical Devices, Pharmaceuticals, Life Sciences, Healthcare or Sterilisation Services.
- Experience writing and executing validation protocols.
- Knowledge of Quality Management Systems and validation principles.
- Strong analytical and problem-solving skills.
- Excellent organisational skills with the ability to manage multiple priorities.
- Strong written and verbal communication skills.
- Good IT skills, including data analysis and report writing.
Desirable
- Experience in sterilisation validation.
- Knowledge of FDA and ISO regulatory requirements.
- Experience supporting equipment qualification projects.
Benefits
- 34 days holiday (26 + 8 Bank Holiday Allowance)
- Medicash Health Plan
- Company pension scheme
- Life Assurance – cover of 4 times your annual salary
- Employee Assistance Programme (EAP)
- Cycle to work scheme
Validation Engineer employer: Sotera Health
Sotera Health is an exceptional employer, dedicated to safeguarding global health through its mission-critical services in sterilization and lab testing. At our Somercotes facility, employees enjoy a supportive work culture that prioritises safety and quality, alongside comprehensive benefits such as 34 days of holiday, a Medicash Health Plan, and opportunities for professional growth within a highly regulated environment. Join us to make a meaningful impact in healthcare while working with a team of over 3,000 passionate individuals committed to excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Validation Engineer
✨Get Hands-On with Temporary Projects
Temporary roles are all about flexibility and quick results. Look for short-term engineering projects or gigs that local companies might need help with. You can find these on job boards like Indeed or even niche platforms like PeoplePerHour. Don't be shy to reach out directly to firms—sometimes they have needs that aren't posted yet!
✨Tap into Engineering Meetups
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Let your friends and family know you're on the hunt for a temporary engineering role. Often, personal recommendations can get you in the door faster than any application. Share your goals and what you’re looking for through social media or casual conversations; you’d be surprised how many people might have the right connections!
✨Stay Sharp with Online Courses
While you're searching, keep those skills fresh! Take on some online courses related to your engineering field. Platforms like Coursera or edX can help you stay current and even get some certifications under your belt. This shows potential employers at Sotera Health that you’re committed to growth, making you a more appealing candidate for temporary roles.
We think you need these skills to ace Validation Engineer
Some tips for your application 🫡
Highlight Your Versatile Engineering Skills:For a temporary engineering role like this one at Sotera Health, make sure to showcase a broad range of your engineering skills. Talk about different projects you’ve undertaken, focusing on your problem-solving ability and adaptability—key traits for temporary positions that depend on quick integration into teams.
Be Clear About Your Availability:Since this is a temporary role, clarity is essential. In your cover letter, be upfront about your availability and how soon you can start. Employers like Sotera Health want to know that you can hit the ground running, so don’t shy away from mentioning your flexibility!
Tailor Your CV to Showcase Relevant Experience:Make sure your CV is tailored to reflect the specific engineering projects relevant to the job. For instance, if you’ve worked on temporary contracts before or have engaged in diverse engineering processes, highlight these experiences to show how well-rounded you are.
Include References from Past Employers:Temporary positions often require trust and reliability. Adding references from previous employers can significantly boost your application. It shows that you have a strong work ethic and can adapt quickly, which is exactly what Sotera Health will be looking for.
How to prepare for a job interview at Sotera Health
✨Get to Grips with Your Technical Skills
Engineering roles often involve assessing your technical expertise, so be prepared to delve into your core skills. Brush up on relevant software and tools you’ve used before, as well as any engineering principles that relate to the position at Sotera Health. We want you to showcase your hands-on experience and problem-solving capabilities – it could be the difference between you and another candidate!
✨Prepare for Problem-Solving Scenarios
Expect to tackle some practical scenarios during the interview. Whether it's a design challenge or a troubleshooting test, Sotera Health might want to see how you approach real-world engineering problems. Think of specific examples from your past work where you had to think on your feet and be ready to walk your interviewers through your thought process.
✨Show Your Adaptability in Temporary Roles
Since this is a temporary position, it’s key to demonstrate your flexibility and ability to hit the ground running. Make sure to convey your eagerness to learn and adapt quickly to the team and the specific projects at Sotera Health. We all know that temporary roles can be a bit of a whirlwind, so emphasise your quick learning skills and your approach to managing change.
✨Highlight Relevant Portfolio Projects
If you've worked on engineering projects that align with the role at Sotera Health, make sure to bring them up! A portfolio can be a great way to illustrate your engineering prowess. Discuss the challenges you faced, the solutions you implemented, and the results achieved – this will give the interviewers a tangible idea of what you bring to the table.
