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Facility Engineer

Ferring Pharmaceuticals A/S


Facility Engineer, GMP/GLP Management

Would you like to join us in a challenging position as a Facility Engineer where your main responsibility would be to establish and maintain compliance towards cGxP/GEP, technical standards and regulatory guidelines for facilities, utilities and related systems?

And would you thrive in managing service programs with external contractors for facilities and utilities e.g. calibrations, service/preventive maintenance and repairs? Then you might be the right person we are looking for.

You will become part of our Facility Management team located in Ørestad.

The Job

Your essential responsibilities include but are not limited to:

Operation and Projects:

  • Ensure that facilities, utilities and related systems comply with all appropriate technical design, installation, commissioning, qualification/validation and operational requirements
  • In collaboration with internal stakeholders and the external contractors, organize, plan and execute specific works efficiently and with good quality of documentation
  • System owner responsibilities for facilities/utilities-related Computerized Systems e.g. Building Management System (BMS), Environmental Monitoring System (EMS) and Access Control System
  • Ensure management and control of building layouts and system specifications and drawings (P&IDs) for Reverse Osmosis Water plant and distribution, as well as gas utilities e.g. nitrogen and compressed air
  • Document and manage events in the deviation management system and handle change requests for facilities and utilities, as well as monitoring of facilities and utilities performance
  • Represent facilities, utilities and their related systems during health authority inspections and audits, and implement related CAPAs
  • Update the technical and validation documentation necessary for GxP compliance – in particular, but not limited to GLP and GMP requirements in collaboration with relevant line functions
  • Establishment and update SOPs for Engineering Quality processes
  • Supervise external suppliers and all external maintenance contracts

Qualifications

  • Engineer or other technical background supplemented with relevant experience
  • Experience (min 3-5 years) of establishing and maintaining facilities, utilities and systems in pharmaceutical industry
  • Experience in establishing/managing Commissioning and Qualification documentation during project and operation phases according to Quality Risk Management
  • Experience as user of quality reporting systems like TrackWise for Deviations, Change Requests (Engineering Change Orders) and CAPAs
  • Management of external contractors and Project Management
  • Core competencies in metrology to assess calibration reports and measurement uncertainties
  • Good knowledge of applicable standards and guidelines for Good Engineering Practices, as well as expert knowledge in GLP/GMP requirements for managing pharmaceutical facilities and utilities
  • Independent and proactive driver (knowing what is needed, and doing it)
  • Strong technical, cross-functional collaboration and interpersonal skills

Contact and application

Please submit application and CV in English no later than 2 June 2020. If you have any questions, you are very welcome to contact Project Director Jacob Hallengreen at direct phone +45 28 78 74 73.

Please note that we review applications on an on-going basis and close the process when we find the right match – the sooner you apply the better are your chances.

Ferring Pharmaceuticals is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. At Ferring International PharmaScience Center (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists working to break new land to help people live better lives. We focus our R&D efforts on peptide-based drugs and biotechnology derived medicines.

As a privately-owned company we benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling our ambition of becoming the world’s leading company within reproductive medicine and women’s health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of us. Read more at ferring.com

Location:

Ferring Denmark



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Ansøg inden 3 dage (02.06.2020)
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Ferring Pharmaceuticals A/S - hurtigt overblik


Ferring Pharmaceuticals A/S
Ferring Pharmaceuticals A/S
Ferring is a research-driven, specialty biopharmaceutical group committed to helping people build healthy families and live better lives. Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology.

Placering
Kay Fiskers Plads 11
2300 København S
Logo: Ferring Pharmaceuticals A/S
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