Senior Engineer - Compliance Engineering

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Engineering
Quality (Engineering)
Facility & Equipment
General
Quality
Quality Control
Quality Assurance
Compliance
Quality Systems
Validation

Engineering
Quality (Engineering)
Facility & Equipment
General
Quality
Quality
Quality Control
Quality Assurance
Compliance
Quality Systems
Validation
Staff
Facilities
Expert Master’s Degree (WO) Permanent Full time 2340 Beerse, Belgium

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

The Beerse 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 Beerse and Olen manufacturing sites. The main goal of the E&PS team 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 is recruiting a senior facilities engineer - Compliance and Quality (C&Q) for the 2 production sites in Beerse and Olen. The position will be based in Beerse (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 cGmP’s 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, NC’s, CAPA’s, CC’s, 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…