Computer Systems Validation Specialist

Gent - Belgium

Monthly Salary: Not Disclosed

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Gent East Flanders Belgium

Job Description:

About Innovative Medicine

Ourexpertisein Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at 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 (CSV) within the CAR-T EMEA program serving the Ghent sites. The role will provide day-to-day execution and support of CSV activities and ensure flawless liaison with the different teams vendors sites and 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 proactive communication an interest in OT/IT systems and a willingness to be hands-on in key aspects.

Tasks and responsibilities

Ensures flawless execution of CSV activities for manufacturing laboratory equipment and when needed facilities and utilities.
Leads Impact Assessments CARAs and qualification documentation per GAMP requirements including the associated VMP.
Serves as owner for CSV including writing/executing protocols FS DS FAT SAT IQ and OQ.
Supports creation of Change Controls URSs and FMEAs as required.
Drives investigations deviations and CAPAs to compliant and timely closure.
Ensures compliance with cGMPs global regulatory requirements safety standards SOPs/WIs and corporate policies including Process Automation engineering (Levels 02) and integrations with MES (Level 3).
Provides CSV leadership and expertise supports/acts as Technical Business Owner for PI Data Historian manages vendors and KPIs and communicates regularly with program stakeholders

Knowledge:

3-5 of experience in pharmaceutical site based or consultancy role
A minimum of 3 years in executing CSV activities
Self-driven and able to set own targets and set priorities under pressure
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)
Project Management certification preferred
Previous experience with Quality Event Management Systems SAP and TruVAULT system is preferred

Education:

Degree in Engineering IT Science or related discipline; Masters preferred.

Languages:

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

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:

Application review: Well carefully review your CV to see how your skills and experience align with the role.
Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally at the end of the process well invite you to share feedback in a short survey your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. Were excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

Required Skills:

Preferred Skills:

Required Experience: