At a Glance
- Tasks: Lead compliance for lab systems and test equipment in medical device manufacturing.
- Company: Join Convatec, a global leader in medical solutions with a caring culture.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic environment with a focus on continuous improvement and career development.
- Why this job: Make a real impact on patient outcomes while working with innovative technologies.
- Qualifications: 5+ years in CSV with strong lab systems knowledge and communication skills.
The predicted salary is between 63000 - 77000 £ per year.
About the Role The Computer Systems Validation (CSV) Senior Compliance Advisor will play a critical role in ensuring that laboratory systems and computer‑controlled test equipment supporting Gx P activities are validated and maintained in a compliant state in accordance with regulatory requirements and corporate quality standards.
This role is heavily focused on laboratory and test environments within a medical device manufacturing organization, including systems and equipment used for product testing, verification, and quality assurance.
The role requires close collaboration with site‑based QC, R&D, Engineering, Validation and Quality teams.
Key Responsibilities
- The CSV Senior Compliance Advisor will support and oversee CSV activities for laboratory systems and test equipment, ensuring systems are inspection‑ready, data integrity principles are applied, and validated systems remain fit for intended use throughout their lifecycle.
- Laboratory & Test Equipment CSV Lead CSV activities for laboratory systems and computer‑controlled test equipment used in medical device development, testing, and manufacturing support.
- Support validation and qualification of test equipment and automated test systems, including software used to control, acquire, process and store Gx P data.
- Ensure appropriate alignment between equipment qualification (IQ/OQ/PQ) and computerized system validation.
- Assess Gx P impact of laboratory instruments, test equipment, software applications and interfaces, including data acquisition, processing and reporting workflows.
- Ensure data integrity (ALCOA+) principles are embedded within laboratory and test systems and associated documentation.
- Partner closely with QC, laboratory, engineering and validation teams to understand workflows and translate them into compliant CSV strategies.
- Implementation Projects
- Evaluate proposed new or modified laboratory systems and test equipment to define appropriate risk‑based validation approaches.
- Work closely with project managers and site stakeholders to ensure CSV milestones are met throughout the project lifecycle.
- Oversee and/or develop validation deliverables, including: Validation Plans User Requirements Specifications (URS) Risk Assessments Traceability Matrices Test Scripts and Protocols Validation Reports Support validation of interfaces between test equipment, laboratory systems and downstream data repositories.
- Review and approve validation documentation to ensure compliance with regulatory requirements and company quality standards.
- Coach project and laboratory teams in the correct execution of CSV documentation and testing activities.
- System Lifecycle & Ongoing Compliance
- Review proposed changes to validated laboratory systems and test equipment and define required change control and revalidation activities.
- Ensure changes are implemented and documented in a compliant manner.
- Perform periodic reviews to confirm systems and equipment remain in a validated state.
- Support investigations into CSV‑related deviations, discrepancies and data integrity issues, ensuring timely resolution and documentation.
- Quality & Regulatory Oversight
- Conduct quality reviews of CSV deliverables to identify risks, gaps and opportunities for improvement.
- Support and perform supplier assessments for laboratory software, test equipment and service providers, applying risk‑based approaches.
- Maintain up‑to‑date knowledge of regulatory expectations and inspection trends related to CSV and test systems in medical device environments.
- Act as a CSV subject matter expert supporting QA, validation and laboratory stakeholders.
Skills & Experience
- Strong understanding of Gx P and medical device regulations, including: 21 CFR Part 820 (QSR) 21 CFR Part 11 EU Annex 11 GAMP 5
- Demonstrated experience validating laboratory systems and computer‑controlled test equipment.
- Experience with laboratory and test systems such as LIMS, CDS, ELN and software controlling or supporting device testing and verification activities.
- Strong understanding of data integrity expectations in laboratory and test environments.
- Experience supporting CSV in medical device manufacturing or development environments.
- Ability to communicate effectively with laboratory scientists, engineers, validation specialists and quality professionals.
- Strong organizational skills with the ability to manage multiple priorities in a regulated environment.
Qualifications / Education
- Bachelor’s degree in Life Sciences, Engineering, Computer Science or related field.
- 5+ years’ experience in CSV, with a strong focus on laboratory systems and/or test equipment.
- Experience in CSV, QA, validation or compliance roles within the medical device industry.
- Excellent documentation, presentation and written communication skills.
- Working Model / Location
This role operates on a hybrid working model, with on‑site presence required.
Travel Requirements
Up to 10% travel, which may include overnight stays.
#LI-AC2 #LI-Hybrid
Equal opportunities Convatec provides equal employment opportunities for all current employees and applicants for employment.
This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
About Convatec
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care.
With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring.
Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at‑risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs.
Convatec's revenues in 2025 were over $2 billion.
The company is a constituent of the FTSE 100 Index (LSE: CTEC).
To learn more please visit: http://www. convatecgroup. com.
Convatec is changing.
We’re transforming our business, fueled by a fierce determination to improve the lives of millions more customers around the world.
Our shared focus, and the sheer drive of our people, are giving us real momentum.
They’re also making us a uniquely invigorating place to work.
Join us and, whatever your role, you’ll be pushed and challenged every day.
You’ll be supported too, empowered to spark and drive change where it matters most.
We have a uniquely dynamic, sometimes demanding environment.
But if you’re motivated, and as focused on delivering for patients as we are, it’ll bring the very best out in you.
You’ll never stand still.
And you might just make the biggest impact of your entire career.
If you would like to know how we intend to use your data following your application please refer to our full data privacy policy on the following link: https://www. convatecgroup. com/privacy-policy/
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CSV Senior Compliance Advisor - Labs & Test Equipment employer: ConvaTec Inc
At Convatec, we pride ourselves on being an excellent employer, offering a dynamic work culture that fosters continuous improvement and innovation. Our Deeside and Rhymney manufacturing sites provide a collaborative environment where employees can thrive, with ample opportunities for professional growth through training and development programmes. We are committed to maintaining a diverse and inclusive workplace, ensuring that every team member feels valued and empowered to contribute to meaningful projects that make a difference in the medical device industry.
StudySmarter Expert Advice🤫
We think this is how you could land CSV Senior Compliance Advisor - Labs & Test Equipment
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like ConvaTec Inc looking for candidates who are engaged and informed.
We think you need these skills to ace CSV Senior Compliance Advisor - Labs & Test Equipment
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at ConvaTec Inc. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at ConvaTec Inc
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with ConvaTec Inc’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
