Emplois actuels liés à Lead Engineer Computer Systems Validation - Gent, Flandre - Johnson & Johnson

  • Associate Computer System Validation

    il y a 4 semaines

    Gent, Belgique Perrigo Temps plein

    Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being. Originating from the...

  • Computer Systems Quality Manager

    Il y a 4 mois

    Gent, Belgique Argenx Temps plein

    We are currently looking for a Computer Systems Quality Manager. Key Accountabilities/Responsibilities: - Develop the Computer Systems (CS) Quality strategy - Manage the CS Quality audit program - Create, review and manage the designated validation deliverables such as System Risk Assessments, Validation/Qualification Plan and respective reports - Support...

  • Computer System Quality Manager

    Il y a 4 mois

    Gent, Belgique MindCapture Temps plein

    COMPUTER SYSTEM QUALITY MANAGER - Biotech- Ghent & remoteWHAT IS OFFERED We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success. We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group...

  • Manager - Application Validation & Quality

    Il y a 3 mois

    Gent, Belgique Argenx Temps plein

    For the expansion of our BIS team, argenx is looking for a (Senior) Manager - Application Validation and Quality. The (Senior) Manager - Application Validation and Quality is responsible for the day to day operations and coordination of all activities relating to the argenx Computer Systems Validation (CSV) Process. This ranges from Initial Impact...

  • Supply Chain Systems Lead

    il y a 1 mois

    Gent, Belgique Argenx Temps plein

    This position offers a unique opportunity to support the build out and shape a global supply chain infrastructure for innovative pharmaceutical products. Reporting Line: Global Supply Chain Lead Key Accountabilities and Responsibilities: - Drive the vision, roadmap, priorities, and development opportunities for the supply chain systems, leveraging...

  • Desktop Support

    Il y a 4 mois

    Gent, Belgique Sharp Brains Ltd Temps plein

    1. The Deskside engineer will be L1 Skill level with at least 1-2 Years of relevant xperience 3. Provides Desktop support and support for Computer hardware systems, memory modules, and peripherals. 4. Handle basic issues related to network end-user devices' security practices and antivirus programs. 5. Ensure that all computers and networks systems run...

  • Quality System Lead

    Il y a 4 mois

    Gent, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Quality System Lead for the CAR-T hub in Europe. The position will be based in Beerse or Ghent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s...

  • Klantendienstmedewerker Rockstar Gezocht in Gent!

    il y a 1 mois

    Gent, Belgique Computer Checkpoint Temps plein

    Ben jij een administratieve duizendpoot die niet alleen van multitasken houdt, maar ook van een goed gesprek? Heb je een zachte, geruststellende stem en een natuurlijke flair voor het verkopen van Telecom diensten via de telefoon? Dan is Computer Checkpoint op zoek naar jou! **Jouw dagelijkse taken**: - Klanten informeren over de nieuwste promoties op het...

  • Frontoffice Medewerker

    Il y a 3 mois

    Gent, Belgique Computer Checkpoint Temps plein

    **Frontoffice Medewerker Gent**: Door onze sterke groei, zijn we op zoek naar een nieuwe collega voor onze **Frontoffice**. De Frontoffice van **Computer Checkpoint**, is de schakel tussen onze klanten (particuliere klanten en bedrijfsklanten) van onze 6 winkels. Met je zachtaardige stem luister je naar de vragen en wensen van onze klanten, activeer je samen...

  • Sr. Manager Quality Systems

    Il y a 4 mois

    Gent, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a Senior Manager Quality System & Engineering for the CAR-T hub in Europe. The position will be based in Beerse or Ghent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created...

  • Protein Science Leader

    Il y a 4 mois

    Gent, Belgique Panda Temps plein

    Job Title: Protein Science Leader Department: Research and Development Reports To: Head of Research and Development Location: Ghent, Belgium Summary: Seeks a visionary Protein Science Leader to spearhead its cutting-edge research initiatives. As a seasoned expert in protein science and structural analysis, you will play a pivotal role in shaping the...

  • Director of IT Applications

    Il y a 3 mois

    Gent, Belgique Cerba Research Nederland Temps plein

    **OBJECTIVES** **In summary, these will be your key objectives and desired outcomes**: - Evaluate project plans, set realistic goals, and establish roadmaps for efficient resource allocation, including tools, manpower, and technology. - Monitor budget and time for financial responsibility and timely project delivery. - Ensure proper technical documentation...

  • Manufacturing Operations Lead

    Il y a 4 mois

    Gent, Belgique Oxford Global Resources Temps plein

    **Manufacturing Operations Lead - Advanced Therapies**: - Location: Ghent, Belgium - Contact: Dardo Helpers - Job type: Contract - Contact phone: +32 15 445 852 - Industry: Pharmaceutical Lead the operational charge in building and scaling two innovative biological manufacturing centers, shaping the future of immunotherapy and directly impacting the...

  • Traineeship - Software Leader

    Il y a 4 mois

    Gent, Belgique Volvo Group Temps plein

    Belgium **Position Description** The Volvo Group Operations Graduate Program is an international fast-track career program with the aim of developing future experts in the field of engineering, IT, data science etc. If you are up for the challenge of driving innovation, gaining first-hand experience, and developing our future operations within a global...

  • Ai System Developer

    Il y a 3 mois

    Gent, Belgique Robovision Temps plein

    **Who are we?** Robovision is a rapidly growing scale-up that develops innovative software solutions to enable the creation of intelligent technological solutions. Our current key focus areas are Agriculture, Manufacturing, Retail and Healthcare. We are combining knowledge and expertise in camera technology, computer vision practices, data science and...

  • Team Lead

    Il y a 3 mois

    Gent, Belgique Bricsys Temps plein

    ------------------------------------------------------------------------ **We are currently seeking a dynamic and experienced Team Lead to oversee our Foundation Team. **This team plays a pivotal role in maintaining and enhancing our CI/CD pipeline and internal tooling that empower our developers to deliver exceptional software products. As a Team Lead,...

  • QA Car-t Qualification Lead Emea

    Il y a 4 mois

    Gent, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson Innovative Medicine is recruiting a CAR-T QA C&Q Lead Engineer for the CAR-T hub in Europe. **CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T-cells and are engineered to...

  • Manufacturing Operations Lead

    Il y a 4 mois

    Gent, Belgique Oxford Global Resources Temps plein

    Location: Ghent, Belgium - Contact: Dardo Helpers - Job type: Contract - Contact phone: +32 15 445 852 - Industry: Pharmaceutical Lead the operational charge in building and scaling two innovative biological manufacturing centers, shaping the future of immunotherapy and directly impacting the trajectory of patient health **Job description** We are seeking...

  • Business System Owner

    Il y a 3 mois

    Gent, Belgique Johnson & Johnson Temps plein

    Position Title: Business System Owner - MES System Location: Ghent - CAR-T For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse...

  • Technical Lead Clean Room

    Il y a 3 mois

    Gent, Belgique MindCapture Temps plein

    TECHNICAL LEAD CLEAN ROOM - Biotech- GhentABOUT THE COMPANY The Technical Lead for Clean Room Operations will play a critical role in ensuring seamless daily production tasks within Manufacturing Operations. This role involves building strong partnerships across various departments, including Quality Control, Quality Assurance, Facilities & Engineering,...

Lead Engineer Computer Systems Validation

Il y a 3 mois

Gent, Flandre, Belgique Johnson & Johnson Temps plein

Job Description - Lead Engineer Computer Systems Validation W)

Description

Are you passionate about improving the lives of cancer patients? We work on the most sophisticated treatment options available today CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system. They are created from the patients' own T cells and are engineered to eliminate cancer cells expressing a specific antigen.
To support the CAR-T program in EMEA, Johnson & Johnson is building two CAR-T manufacturing centers in the Ghent area (Belgium) and new build Lab's and warehouse will be operated from the existing Johnson & Johnson Beerse site.
We are establishing the Asset Management / Engineering & Technical Services organization which will ensure that the entire asset portfolio and associated business processes for Janssen's Advanced Therapies Supply Chain regionally are in place, are compliant and run efficiently day-by-day.

What you will be doing:
In this role you will provide compliance expertise, leverage best practices, oversight and develop internal as well as external partnerships with focus on Computer System Validation within the CAR-T EMEA program serving the Beerse and the Ghent sites. The role will provide day-to-day management of CSV activities and ensure flawless liaison with the different teams, vendors, sites, and stakeholders. In addition, the role holder creates and sustains continuous procedural improvements to boost efficiency of CSV activities. During health authority inspections and audits s/he is the first point of contact for computer validation related matters and in a leading role to ensure successful outcomes. The ideal candidate will possess a strong track record in commissioning and qualification, especially CSV, as well as engineering, proactive communication, and a willingness to be hands-on in key aspects.

What impact will you also have:
You will get an opportunity to utilize your strong track record in Computer System Validation to help deliver life-saving treatment to cancer patients.

In your day-to-day job you will:

• Ensures flawless execution of CSV works for manufacturing and laboratory equipment and as needed also for facilities and utilities

• Leads the writing and execution of Impact Assessments, CARA's, qualification documents according to GAMP requirements and most importantly the associated VMP

• Owner for computer systems validation incl. writing and executing CSV protocols, FS, DS plus Functional Acceptance Test (FAT) and Site Acceptance Test (SAT), Integration testing (IQ) and Functional testing (OQ)

• Supports creation of Change Control's, URSs, as well as FMEA's as needed

• Drives investigations, deviations, corrective and preventive actions towards successful and compliant closure

• Assures compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and Company policies and corporate standards

• Ensure compliance in the field of Process Automation engineering (Levels 0-2); OSI-PI, Equipment PLC, SCADA, IDP (Instrument Data Platform), Middleware, and integrations with MES (Level 3)

• Provide leadership and act as true expert in the field of CSV

• Support or act as Technical Business/Process Owner for the site's PI Data Historian

• Manage partnerships with contractors and vendors

• Establishes and manages KPI's and tracking tools

• Actively communicates with program stakeholders on a regular basis

Qualifications

We would love to hear from you, if you have the following essential requirements:

• Degree in Engineering, Science, or related discipline; Masters preferred.

• 3-5 of experience in pharmaceutical site based or consultancy role

• A minimum of 3 years in leading C&Q or CSV activities

• A minimum of 3 years in executing CSV activities

• Previous experience with international health authority inspections as well as internal and external audits

• Self-driven and able to set own targets and set priorities under pressure

• In depth knowledge of current GMP standards and GAMP guidelines related to computer systems (e.g., 21 CFR part 11; EU GMP Annex 11, Data Integrity, ISA-88 Standards for Process Control / ISA-95 Standards of Automated Interfaces, ICH, FDA, FAGG/FAMHP, ISPE)

• Previous experience working in a large matrix-managed environment preferred

• Project Management certification preferred

• Previous experience with Quality Event Management Systems, SAP and TruVAULT system is preferred

• Fluent in English (written and spoken), Dutch language at level C1 preferred

• Proactive, open team player with a service mindset

• Working across project sites in Ghent and Beerse as required

What type of mark will you make?
By joining Johnson&Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world's healthiest workforce you can strengthen your body as well as your mind. When you work at Johnson&Johnson you can touch over a Billion of lives worldwide every day. And when you apply your talent to our collective purpose there's no end to the lasting impact we can make together. And that changes everything.

Diversity, Equity & Inclusion at Johnson&Johnson means that "YOU belong"
For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and every one of our people feels that they belong and can reach their potential. No matter who they are.

Primary Location Primary Location Europe/Middle East/Africa-Belgium-East Flanders-Ghent

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.andEqual Employment Opportunity Posters GINA Supplement.

If you are an individual with a disability, please check ourpage for information on how to request an accommodation.Disability Assistance

This site is governed solely by applicable U.S. laws and governmental regulations. Please see our. Use of this site constitutes your consent to application of such laws and regulations and to our. Your use of the information on this site is subject to the terms of our. You should view thesection and the most recent SEC Filings in thesection in order to receive the most current information made available by Johnson & Johnson Services, any questions or search this site for more information.Privacy Policy Privacy Policy Legal Notice News Investor Contact Us

#J-18808-Ljbffr