Senior Engineer Compliance Engineering

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

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Johnson & Johnson brings innovative medicines to patients around the world. Within J&J E&PS FM is responsible for managing the facilities and utilities at all Belgium the scope of E&PS FM includes the sites in Beerse Geel Olen La Louvière Courcelles and Ghent.

In Ghent J&J is operating CAR-T: chimeric antigen receptor T-cell therapy. This is a new and innovative approach to eliminate cancer cells. It works by harnessing the power of a patients own immune system. That power is created from the patients T cells and is engineered to eliminate cancer cells expressing a specific antigen.

The Ghent E&PS FM team manages the critical installations facilities and utilities (steam cooling installations heating equipment water systems compressed air high voltage) of/for the Ghent manufacturing hubs. The main goal of the E&PS team in Ghent is to ensure that the building and building systems are available 24/7 in a safe and compliant manner for the occupants and their activities. The EP&S FM team in Ghent is recruiting a Senior Compliance Engineer- Compliance and Quality (C&Q) for the 2 production sites in Ghent and its future expansions. The position will be based in Ghent (Belgium) reporting into the senior facilities manager.

As a Senior Engineer - Compliance Engineering:

We are seeking an experienced Compliance & Quality engineer. This position is responsible for ensuring that the facilities and utilities (F&U) activities are operated in a compliant way. Together with the rest of the team we must ensure that the premises are brought and maintained upon the required quality level.

The ideal candidate must possess an exquisite quality mindset combined with strong analytical capabilities and the means to understand and grasp technical matters. The role must be taken up by someone reliable and trustworthy whose actions must be just and ethical. Along with communication skills an absolute prerequisite is being stress resilient.

The responsibilities and the impact YOU will have:

Facilities Asset Maintenance - Acts as professional expert to ensure compliant F&U. This includes strict application of cGmPs and quality procedures.
Sets-up action plans and programs to improve the compliance performance.

Coordinating change management (Change Control).
Monitoring the qualified status of systems managing validation master plans (VMPs) and proactively implementing regulations.
Documenting and archiving technical and GxP-critical files.
Managing and tracking deviations.
Drafting monitoring and adjusting Service Level Agreements (SLAs).
Owning specific compliance aspects across the entire CAR-T footprint.

• Work Management & Optimization
  Continuous apply the kaizen and compliance mindset.
  This position must have close and sustainable connections with the entire E&PS FM team and with the other QA departments.
• Facilities Compliance & Safety
  Ensure all activities are managed in accordance with QMS.
  Ensure the technical installations and the equipment within the scope of E&PS FM comply with the legal requirements.
  Ensure audit readiness for the CarT installations and buildings within the E&PS FM scope.
  This role is the E&PS FM representative during audits and inspections of all kind including the related preparations.
  Performing Periodic System Quality Reviews (PSQR).
  Ensure effective closure on QMS documents (audit actions NCs CAPAs CCs maintenance records ).
  Implementation of EHS requirements in general.
  Contribute to and live a proactive safety culture.
• Leadership & Team Development
  The E&PS FM CarT team is an unimaginably strong and gifted team. Fitting into this fantastic team is an absolute must.
  Very short lines with your colleagues peers coworkers central compliance engineering team are indispensable. Therefore on-site presence is required.
• System & Data Management
  Proficiently work with and within the computerized maintenance management systems (CMMS) and within the compliance and quality related platforms such as Comet ICR and Truvault.
  Ensure effective and high-quality data maintenance.
  Reviews and approves qualification plans protocols and reports.
• Key Relationships
  Establish and maintain excellent relationships with key internal and external stakeholders and our partners.
  Close collab with the entire team is crucial in order to deliver high-end root cause analyses to identify correct countermeasures to review proposed countermeasures and to review incoming CCs.

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

• Masters degree in engineering life sciences or equivalent experience required. Excellent C&Q knowledge (Minimum of 2 years) is required. Capability to understand technical matters and approach these matters from a C&Q perspective.
• Outstanding team player skills. Great empathy. Strict but fair. Just and ethical. Strong relationship building skills are required.
• Experienced in GxP and quality management.
• Excellent communication analytical and problem-solving abilities.
• You know how to deal with continuously meeting tight timelines. You are extremely stress resistant.
• You are willing to accept peak loads that manifest themselves in long days and long weeks and this several times per year (the shutdowns).
• You possess an outspoken can do mentality.
• You are highly communicative both written and spoken. Besides having a perfect command of Dutch you speak and write English fluently. Other languages are an additional asset.

Are you ready to make an impact

If you want to leave your personal mark and be valued for who you are Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

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