AGC Biologics A/S | Equipment Qualification Scientist in QC, Operational Readiness

Are you looking for an exciting job in an expanding international company producing new biological medicines? Do you thrive in a dynamic environment, in a department with skilled colleagues in an organization where we work as one team?

Then, we have the ideal opportunity for you since Quality Control (QC) at AGC Biologics A/S (AGC) is looking for an Equipment Qualification Scientist for our brand-new QC laboratory, that is currently under construction.

About the organization

At AGC we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical testing and marketing. Since we are a contract manufacturing development organization, a high level of service to our clients is in focus.

The QC organization consists of 160 dedicated colleagues, and we are responsible for supporting the production of new biopharmaceuticals by performing analytical testing of samples from the production and stability programs. A prerequisite for this is, that all our equipment is in a qualified state.

AGC is growing - we are building a new facility next to our existing facility in Søborg, including a state-of-the-art QC laboratory. To support the expansion of the QC laboratories, we have established a new QC Planning & Systems Department. The department is owner of all equipment in QC and responsible for life cycle management activities such as preparation of URSs, procurement, qualification, maintenance, (re)qualification/calibration, and decommissioning. All activities are performed in compliance with cGMP.

Tasks and Responsibilities

As equipment qualification scientist in QC Planning & Systems, you will be responsible for ensuring that analytical instruments for our new facility is qualified in due time to allow expansion of our analytical capacity. This means that you will be authoring URSs, and associated qualification documentation. You will participate in practical qualification, and you will coordinate qualification activities between equipment vendor and AGC. The equipment to be qualified varies in size and complexity from:

• Simple equipment such as Milli-Q systems and climate chambers
• Large equipment such as BSCII and dishwashers
• Simple analytical equipment such as balances and pH-meters etc
• Complex analytical equipment such as HPLCs, CEs, NIR, ELISA readers, qPCR instruments etc.

The extend of your tasks and responsibilities will depend on your experience, qualification, and preferences

Application

For further information regarding the position, please contact Director Palle Rasmussen at prasmussen@agc.com. We treat the applications as we receive them and conduct interviews with qualified candidates. When the right candidates are found, the add will close.      

AGC offers

AGC offers a dynamic working place with good opportunities of working with a varied array of manufacturing tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extent be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude, and we help each other to reach deadlines together as one team.

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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.

Qualifications

The ideal candidate holds a MSc or PhD degree in natural science or engineering. You have knowledge of cGMP and preferably experience from a similar position.

To succeed in this position:

• You work effective and systematic, and have good communication and interpersonal skills
• You have capacity to prioritize your own tasks in a dynamic environment
• You can interact positively within a team and in close collaboration with other working areas when needed.

It is important to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. Furthermore, you thrive in a challenging and dynamic environment and enjoy a rapid pace of work. You bring a positive, can-do attitude and a good sense of humor.