Would you like to be a part of AGC Biologics growing success?

At AGC Biologics A/S we work with development and GMP manufacturing of APIs for both commercial products and products in all clinical phases. We are a client centric CDMO, and the partnership with our clients, working side by side with the clients, is our focus.

We are looking for a HVAC Lead to ensure requirements for utility systems in our new EUR 160 million Mammalian Manufacturing Facility. AGC Biologics is in a period of rapid growth and you will play an important role in getting new capacity ready to continue our growth journey.

The department and project team 
You will be part of a project team consisting of project managers, other functional leads as well as EHS, PM support and subject matter experts. Some will be full time and some part time on the project. During the project you will report to one of our project managers in the project.
In the line organization you will be part of the Engineering and Operations Support (EOS) department responsible for execution of technical projects including facility projects as well as operation of all utility and facility systems, maintenance and calibration across our current facility. The department consist today of  41 employees with Project Managers, Engineers, Compliance Specialist and Technicians. 

 

The position

The lead for our HVAC Utility will ensure that AGC requirements are fulfilled for a range of utility systems such as ventilation.

AGC has partnered with an engineering company for the execution of this project. The  design is established and there is now focus on execution of the contracts with vendors

Your role in the project are:

  • Effectively managing the communication between the counter part in the engineering company and internal stakeholders involved in the project.
  • Ensuring that all work is carried out and installation implemented is safe, effective and in compliance with the appropriated industry standards and authority regulations.
  • Ensure that company, site policies and procedures are adhered to.
  • Support that  systems are handed over effectively to end users.
  • Work closely with other stakeholders in the organization.

After the project, you will be a part of the Support and Compliance team, which are handling:

  • The day-to-day support to the facility management and the technical operations in EOS
  • GMP support to major projects driven by the EOS department
  • Coordinate minor projects in the department
  • Handling GMP documentation such as procedures, deviation and change control
  • Work closely on daily basis with our stakeholders in manufacturing and other areas

 

 

Your profile

  • Relevant Engineering degree - preferably within the mechanical or chemical area
  • 5+ years of operations or engineering experience in the biopharmaceutical industry including experience working under GMP
  • Experience from executing facility projects – either on the end user side or from an engineering company
  • Hands-on experience with utility systems – preferably HVAC systems
  • Knowledge about automation and control systems.
  • You focus on quality and work in a structured way
  • The ability to work effectively under pressure
  • Knowledge of the qualification process for pharmaceutical manufacturing facilities
  • Good communication skills – including the ability to communicate clearly and professionally in written and spoken English and Danish is preferred

How to apply
Send your application as soon as possible as we process the applications as we receive them.

If you need further information about the position, please feel free to contact Dorthe Christensen, Team leader of EOS, Support and Compliance +45 2566 0090.

 

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

 

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

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