Performance and Validation Expert

4 weeks ago


Cardiff, Cardiff, United Kingdom Ipsen Biopharm Ltd Full time

Ipsen Biopharm Ltd is a dynamic and innovative biopharmaceutical company focused on delivering high-quality products and services to our customers.

We are seeking a skilled Validation and Quality Assurance Specialist to join our team and contribute to our mission of making a positive impact on people's lives.

In this role, you will be responsible for supporting the engineering team in defining, executing, and reporting on validation maintenance activities associated with facilities, utilities, and process equipment.

You will perform routine system reviews, hands-on requalification activities, and ensure optimal performance and output.

Additionally, you will contribute to a risk-based validation approach through participation in risk assessment and the implementation of Continuous Improvement initiatives.

Key responsibilities

  • Define, execute, and report qualification and re-qualification studies to maintain the qualified status of facilities, utilities, equipment, and processes.
  • Subject Matter Experts for specific validation activities, including presenting packages to internal and external auditors.
  • Investigate and resolve non-conformances encountered during requalification and periodic review activities.
  • Contribute to a risk-based validation approach through participation in risk assessment and the implementation of Continuous Improvement initiatives.

Key requirements

  • Prior experience in a pharmaceutical, biotech, cleanroom, or GMP environment.
  • Good understanding of validation lifecycles and current regulatory requirements.
  • Knowledge of industry guidance and standards associated with validation activities.
  • Experienced in the execution of qualification and validation activities.
  • Appreciation for technical, compliance, and practical understanding of specific qualification activities.
  • Basic understanding of quality risk assessment principles and tools.
  • Competent in the generation and review of technical documentation.

Why Ipsen Biopharm Ltd?

  • We are a growing and dynamic company with a wide range of opportunities and exciting challenges.
  • We are committed to Diversity & Inclusion and have a fantastic culture and working environment.
  • We have a genuine focus on the environment and sustainability.
  • We offer competitive salaries and an enhanced benefits package.
  • We are a proud company that directly impacts and changes lives for the better.


  • Cardiff, Cardiff, United Kingdom Proclinical Staffing Full time

    Job Title: Senior Validation EngineerAs a key member of our engineering team, you will play a critical role in ensuring the optimal performance and output of our facilities, utilities, and process equipment. Your primary focus will be on supporting the engineering team by defining, executing, and reporting on validation activities.We are expanding our...


  • Cardiff, Cardiff, United Kingdom Ipsen Biopharm Ltd Full time

    Ipsen Biopharm Ltd is a dynamic and growing specialty-driven biopharmaceutical company focused on innovation and patient care. We are committed to attracting and developing bold, agile, and entrepreneurial individuals who take ownership of their decisions and make a direct impact through their work in people's lives.The role of Validation Specialist at Ipsen...

  • Senior Product Analyst

    22 hours ago


    Cardiff, Cardiff, United Kingdom Yolk Recruitment Full time

    As a Senior Product Analyst - Commercial Expert, you will be working with one of the fastest growing FinTech organisations in the UK. They are a Financial Services client focused on using AI tools and technology to make their customers' lives easier.The role involves defining and refining key performance metrics that influence product strategies. Conduct...


  • Cardiff, Cardiff, United Kingdom Hays Accountancy and Finance Full time

    Our company, Hays Accountancy and Finance, is seeking a highly skilled Financial Expert to join our team in the renewable sector. This is an exciting opportunity to work with a leading energy company, utilizing your commercial expertise to support business case assessments and decision-making.We are looking for a qualified accountant with experience in...


  • Cardiff, Cardiff, United Kingdom GAP Group Ltd. Full time

    Regional Pump Engineer OpportunityGAP Group Ltd. is a leading provider of pump services, solutions, and equipment in the UK. We are seeking an experienced Regional Pump Engineer to join our high-performing team in Cardiff.This role offers a competitive salary of £45,000 - £55,000 per annum, depending on experience, as well as a range of benefits including...


  • Cardiff, Cardiff, United Kingdom Welsh Ambulance Service University NHS Trust Full time

    We are seeking a highly skilled Data Governance Quality Analyst to support the Trust's data quality efforts. This is an excellent opportunity for a detail-oriented individual to progress their career in data and contribute to improving patient safety and outcomes.Key ResponsibilitiesEnsure high-quality data and information used for reporting, performance,...


  • Cardiff, Cardiff, United Kingdom Medstrom Full time

    Job OverviewClean and Repair Technicians are required to work on a six month fixed term contract in Cardiff, South Wales. The position involves operations and is full time.Salary and BenefitsThe estimated salary for this role is around £25,000 - £30,000 per annum. This figure may vary based on factors such as location and experience.Job ResponsibilitiesAs...


  • Cardiff, Cardiff, United Kingdom Hubstaff Full time

    About the RoleWe are seeking a skilled Webflow Expert who has experience building and optimizing websites with a focus on performance, SEO, and user experience.


  • Cardiff, Cardiff, United Kingdom Hays Accountancy and Finance Full time

    Your new company is a top 35 award-winning practice that has relocated to Cardiff to establish a new Tax Centre of excellence. This presents an exceptional opportunity to work with a firm boasting an outstanding reputation across the South West.Provide high-level tax advisory servicesOffer guidance on business restructuring and technical tax mattersSupport...


  • Cardiff, Cardiff, United Kingdom GatenbySanderson Full time

    Job Title: Digital Transformation ExpertCompanies House is seeking a Digital Transformation Expert to join its Board as a Non-Executive Director. The ideal candidate will have experience in implementing data governance, advanced analytics capabilities, and cybersecurity programs, as well as the associated cultural change.Key Responsibilities:Support the...

  • HSE Advisor

    2 days ago


    Cardiff, Cardiff, United Kingdom ASafe Global Full time

    Join Our Team as a Compliance and Risk ProfessionalASafe Global is seeking a seasoned Compliance and Risk Professional to join our team in Cardiff, Wales. As a member of our team, you will play a critical role in ensuring compliance with local and international regulations, implementing robust health and safety measures, and fostering a safety-centric...


  • Cardiff, Cardiff, United Kingdom Spherical Search Full time

    Key ResponsibilitiesSpherical Search has partnered with a leading analytical testing/CRO company to develop innovative and safe products. We are seeking a Senior Planning Specialist to operate as a scientific and technical expert in aerosol formulation.Key responsibilities include:Understanding physical-chemical characterisation to a high degree to profile...


  • Cardiff, Cardiff, United Kingdom Starling Bank Limited Full time

    Job Title: Regulatory Monitoring ExpertStarling Bank Limited is seeking a talented individual to join its Conduct and Compliance Oversight team as a Regulatory Monitoring Expert. In this key role, you'll be responsible for providing second line of defence (2LoD) conduct and compliance oversight over 1LoD, including Outcomes Testing, Internal & External...


  • Cardiff, Cardiff, United Kingdom Sigma Full time

    Role OverviewThis Electrical Inspector position is a key role in our plant, responsible for ensuring the smooth operation of engineering assets. As a technical expert, you will be proactive in identifying and addressing any deviations in equipment performance, supporting electrical maintenance technicians, and collaborating with contractors to ensure...


  • Cardiff, Cardiff, United Kingdom Hydrock Full time

    We are seeking a highly skilled Electrical Engineering Expert to join our team in Cardiff. As a Senior Electrical Engineer, you will be responsible for leading multidisciplinary projects across various building sectors, developing relationships with clients and project managers, and identifying opportunities for other disciplines to become involved.Key...

  • Employment Expert

    22 hours ago


    Cardiff, Cardiff, United Kingdom Corecruitment Full time

    We are looking for a highly skilled HR professional to lead our Human Resources function. The successful candidate will have a deep understanding of employment law, HR policies and processes, and will be able to provide expert advice and guidance to the management team.The key responsibilities of this role include:To assist with the management of all budgets...


  • Cardiff, Cardiff, United Kingdom G2 Recruitment Full time

    About G2 RecruitmentG2 Recruitment is a global agency specializing in talent solutions across various industries. With offices in the UK, Europe, and the US, we've grown internationally and developed our trainee consultants into experts through our organic growth model.Job SummaryWe are seeking an Expert Recruitment Specialist to join our team. As a...

  • Webflow Expert

    1 month ago


    Cardiff, Cardiff, United Kingdom Hubstaff Full time

    We are seeking a skilled Webflow Expert to join our team at Embarque.io. As a key member of our team, you will be responsible for designing, developing, and maintaining websites on Webflow, ensuring they are optimized for search engines and aligned with our SaaS products.Key Responsibilities:Build, update, and maintain Webflow websites for Embarque.io and...

  • EHS Manager

    1 month ago


    Cardiff, Cardiff, United Kingdom Consult Full time £80,000

    EHS Manager - Performance ChemicalsOur client, a leading global specialty chemicals and performance materials company, is seeking an EHS Manager to provide strategic leadership and expert advice in all aspects of personal safety, health, and security for a dynamic hazardous process manufacturing site and remote employees across the UK.Key...


  • Cardiff, Cardiff, United Kingdom Monzo Full time

    Embracing a culture of innovation, Monzo is on a mission to revolutionize the traditional banking experience.We're seeking a skilled Financial Performance Analyst to join our dynamic team in London or Cardiff, with the option for distributed working within the UK. This exciting role offers a unique opportunity to make a significant impact on our financial...