Senior Validation Engineer

il y a 3 semaines

Toulouse, Occitanie, France Evotec WD Temps plein

Senior Validation Engineer - Analytical Equipment

Evotec WD is in search of a dedicated Analytical Equipment Validation Engineer eager to make a substantial impact on global access to biotherapeutics. This role primarily involves supporting the Commissioning, Qualification, and Validation (CQV) processes for facility start-up activities, particularly concerning Analytical Equipment. The responsibilities encompass all stages of the validation lifecycle, from system implementation and qualification to ongoing support and eventual retirement of systems.

Key Responsibilities:

  • Assist in the creation and/or evaluation of essential deliverables, including User Requirements Specifications, System Impact Assessments, Criticality Assessments, Data Integrity Assessments, Design Qualification, Requirements Traceability Matrices, and protocols for Commissioning, IQ, OQ, and PQ related to Analytical Equipment.
  • Collaborate with a diverse team, including external partners, consultants, Quality Control, Manufacturing, Process Engineers, E&HS, and Quality departments.
  • Ensure the timely generation of CQV documentation.
  • Participate in the execution of CQV activities, including commissioning, IQ, OQ, and PQ.
  • Contribute to the resolution of Validation deviations through troubleshooting and root cause analysis.
  • Conduct Periodic Reviews and Requalifications of qualified equipment, systems, and utilities to confirm their suitability for intended use and compliance with industry regulations and company policies.
  • Aid in the development of qualification and validation programs at Evotec WD.
  • Formulate phase-appropriate strategies to meet regulatory requirements.
  • Support readiness for inspections, Health Authority and Client audits, and implement corrective actions based on audit findings.
  • Assist in the implementation of a Computerized Maintenance Management System (CMMS).
  • Engage in Document Control Management activities, including electronic storage architecture and rights management.

Position Requirements:

  • Master’s degree in engineering or a related field with over 8 years of relevant experience in a GMP environment.
  • Knowledge of industry standards and best practices for a science and risk-based approach to the qualification of analytical equipment.
  • Familiarity with US FDA CFRs and European EMA regulations, including ICH guidelines.
  • Understanding of European, US, and Japanese Pharmacopeia regulations concerning Analytical Equipment Qualification.
  • Experience in authoring and reviewing validation documentation.
  • Proficiency in quality risk management.
  • Knowledge of analytical equipment operations and engineering principles.
  • Strong attention to quality and detail.
  • Excellent problem-solving and critical thinking abilities.
  • Self-motivated with a strong mechanical aptitude.
  • Ability to work independently and collaboratively across various disciplines in a dynamic environment.
  • Effective organizational and time management skills.
  • Strong analytical and synthesis capabilities.
  • Adaptability to a working environment where team members and SMEs are still onboarding and the Quality System is being established.
  • Proficient verbal and written communication skills in English and French.

Additional Preferred Qualifications:

  • Familiarity with Paperless Validation Software (e.g., Kneat).
  • Ability to apply knowledge and expertise to resolve complex technical challenges.
  • Significant contributor to multi-disciplinary teams at the functional level.
  • Working knowledge of Computer Systems Validation.
  • Understanding of Qualification processes for Manufacturing equipment.

About Evotec WD

Evotec WD is a pioneering platform company that integrates the design, engineering, development, and manufacturing of biologics. With extensive experience in protein, process, and manufacturing sciences, our team is committed to overcoming scientific and technical challenges that hinder access to life-changing protein therapeutics. Our focus is on creating value and accessibility for a global market through scientific and technological innovation.

  • Senior Radar Systems Validation Engineer

    il y a 2 semaines

    Toulouse, Occitanie, France ITL-FR (Services) Temps plein

    Job SummaryWe are seeking a highly skilled Senior Radar Systems Validation Engineer to join our team at ITL-FR (Services) in the electronics sector. The successful candidate will be responsible for ensuring the quality and reliability of our radar systems through thorough validation and characterization.Key ResponsibilitiesDevelop and execute comprehensive...

  • Senior Validation Engineer

    il y a 3 semaines

    Toulouse, Occitanie, France Evotec WD Temps plein

    Position: Senior Validation Engineer - Analytical SystemsEvotec WD is on the lookout for a dedicated and skilled Analytical Systems Validation Engineer who is eager to make a meaningful impact in enhancing global access to biotherapeutics.The main objective of this position is to assist in the Commissioning, Qualification, and Validation (CQV) of facilities,...

  • Senior Validation Engineer

    il y a 2 jours

    Toulouse, Occitanie, France NXP Semiconductors Temps plein

    Senior Validation Engineer – Automotive Radar IPContribute to the Development of Life-Saving Automotive Radar TechnologyNXP Semiconductors is seeking a highly skilled Senior Validation Engineer to join our Automotive Radar team in Toulouse. As a key member of our team, you will play a crucial role in the development of advanced radar systems for autonomous...

  • Senior Validation Engineer

    il y a 2 jours

    Toulouse, Occitanie, France Evotec WD Temps plein

    About the RoleWe are seeking a highly motivated and experienced Senior Validation Engineer - Analytical Equipment to join our team at Evotec WD. As a key member of our Commissioning, Qualification and Validation (CQV) team, you will play a critical role in supporting the start-up activities of our facilities, including Analytical Equipment.Key...

  • Senior Validation Engineer

    il y a 2 jours

    Toulouse, Occitanie, France Evotec WD Temps plein

    About the RoleWe are seeking a highly motivated and experienced Senior Validation Engineer - Analytical Equipment to join our team at Evotec WD. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our analytical equipment.Key ResponsibilitiesDevelop and implement validation strategies...

  • Senior Principal Validation Engineer

    il y a 2 jours

    Toulouse, Occitanie, France NXP Semiconductors Temps plein

    Senior Principal Validation Engineer – Automotive Radar IPContribute to the Development of Life-Saving Automotive Radar TechnologyNXP Semiconductors is seeking a highly skilled Senior Principal Validation Engineer to join our Automotive Radar team in Toulouse. As a key member of our team, you will play a crucial role in the development of advanced driver...

  • Senior Validation Engineer

    il y a 3 jours

    Toulouse, Occitanie, France Just - Evotec Biologics Temps plein

    About the Role:We are seeking a highly motivated Senior Digital Systems Validation Engineer to join our team at Just - Evotec Biologics. As a key member of our team, you will play a critical role in supporting the validation of computerized systems, manufacturing equipment, facilities, and utilities, as well as analytical equipment and systems.Key...

  • Senior Software Engineer

    il y a 3 jours

    Toulouse, Occitanie, France Artemis Chase - Space Talent Temps plein

    Job Title: Senior GNC EngineerLocation: Competitive Salary PackageAbout Us: Artemis Chase - Space Talent is dedicated to pushing the boundaries of in-orbit services with cutting-edge spacecraft driven by our innovative Rendez-Vous solution—an advanced Autonomous Vision-Based Navigation Solution.Job Summary: We are seeking a highly skilled and motivated...

  • Senior Service Engineer M/F

    il y a 21 heures

    Toulouse, Occitanie, France Artemis Chase - Space Talent Temps plein

    Job Title: Senior GNC EngineerLocation: Competitive Salary PackageArtemis Chase - Space Talent is dedicated to pushing the boundaries of in-orbit services with cutting-edge spacecraft driven by our innovative Rendez-Vous solution—an advanced Autonomous Vision-Based Navigation Solution.We are seeking a highly skilled and motivated Senior GNC Engineer to...

  • Senior Analog Design Engineer

    il y a 2 jours

    Toulouse, Occitanie, France NXP Semiconductors Temps plein

    Job DescriptionJob Title: Senior Analog Design EngineerJob Summary:NXP Semiconductors is seeking a highly skilled Senior Analog Design Engineer to join our Advanced Automotive Analog (AA) Business Unit. As a key member of our team, you will be responsible for designing analog or mixed-signal blocks for battery management circuits from architecture to...

  • Senior Biotech Engineer

    il y a 2 jours

    Toulouse, Occitanie, France Optimus Life Sciences Temps plein

    About the RoleWe are seeking a highly skilled Senior Biotech Engineer to join our team at Optimus Life Sciences. As a key member of our engineering team, you will be responsible for validating process control systems, spreadsheets, and benchtop equipment.Key ResponsibilitiesValidate process control systems to ensure accuracy and efficiencyDevelop and...

  • Senior Analog Design Engineer

    il y a 2 jours

    Toulouse, Occitanie, France NXP Semiconductors Temps plein

    Job DescriptionCompany OverviewNXP Semiconductors is a leading provider of high-performance mixed-signal technologies for automotive applications. Our Advanced Automotive Analog (AA) Business Unit is dedicated to delivering a broad portfolio of differentiated analog, mixed-signal, wireless, and energy management solutions for the automotive market.Job...

  • Electronics Validation Engineer

    il y a 22 heures

    Toulouse, Occitanie, France Astek Temps plein

    About the Role:We are seeking a skilled Electronics Validation Engineer to join our team in Toulouse. As an Embedded Systems Validation Specialist, you will be responsible for ensuring the quality and reliability of electronic calculators used in the energy sector.About Astek:Astek is a global engineering and technology consulting company founded in France....

  • Senior Project Manager

    il y a 6 jours

    Toulouse, Occitanie, France NXP Semiconductors Temps plein

    Contribute to the Future of Automotive Radar TechnologyNXP Semiconductors is seeking a highly skilled Senior Project Manager to join our Automotive Radar team in Toulouse. As a key member of our team, you will be responsible for leading the validation of our next-generation radar chip.Your Key Responsibilities:Lead and motivate a team of validation engineers...

  • Senior Software Applications Engineer

    il y a 3 semaines

    Toulouse, Occitanie, France Qorvo Temps plein

    Senior Software Applications Engineer Experience Level: Individual Contributor Job Type: Full-Time Location: France - Toulouse, FR Company Overview: Qorvo (Nasdaq: QRVO) delivers cutting-edge semiconductor solutions that enable a better world. We integrate product and technology leadership, systems-level expertise, and global manufacturing capabilities to...

  • Senior RADAR Software Application Engineer

    il y a 2 jours

    Toulouse, Occitanie, France NXP Semiconductors Temps plein

    Senior RADAR Software Application EngineerAbout the RoleWe are seeking a highly skilled Senior RADAR Software Application Engineer to join our team at NXP Semiconductors. As a key member of our Radar System and Application group, you will be responsible for developing and validating advanced radar software solutions for automotive applications.Key...

  • Senior Staff Software Engineer

    il y a 2 jours

    Toulouse, Occitanie, France IC Resources Temps plein

    Job Summary: We are seeking a highly skilled Senior Staff Engineer to join our team at IC Resources. As a Senior Staff Engineer, you will play a key role in the development of our award-winning IoT cloud platform.About the Role: This is a backend-focused position that offers high ownership and the opportunity to learn new technologies. You will be working...

  • Senior Process Engineer

    il y a 2 jours

    Toulouse, Occitanie, France Evote Temps plein

    About the RoleWe are seeking a highly motivated Senior Process Engineer to join our team at Evotec Biologics. As a key member of our New Product Introduction (NPI) team, you will be responsible for leading activities related to the introduction of new products to our J.POD Toulouse team.Key ResponsibilitiesPartner with Process Engineering and Digital...

  • Senior Study Engineer CVCD

    il y a 3 jours

    Toulouse, Occitanie, France Work&You Temps plein

    **About Us**Work&You is a leading player in the construction industry, offering innovative and sustainable solutions. We are currently seeking a Senior Study Engineer CVCD to join our teams in Bordeaux, Toulouse, or Montpellier.**Job Summary**We are looking for a highly skilled and experienced Study Engineer CVCD to analyze technical, financial, and...

  • Senior Field Applications Engineer

    il y a 3 jours

    Toulouse, Occitanie, France Qorvo Temps plein

    Job SummaryWe are seeking a highly skilled and experienced Senior Field Applications Engineer to join our team at Qorvo. As a key member of our sales and marketing team, you will be responsible for providing technical support and guidance to our customers, ensuring their successful adoption and implementation of our wireless solutions.Key...