AGC Biologics A/S | Experienced Scientist for Facility Compliance

With AGC Biologics increasing activities, we are looking for a new scientist with experience within Facility compliance in the pharmaceutical industry.

AGC Biologics is a Contract Manufacturing Organization (CDMO) with facilities in Denmark, Germany, Japan and USA and with customers from all over the world. We have more than 50 nationalities employed and the daily language is English.

The Facility Compliance team

The Facility Compliance team is supporting all the manufacturing departments with tasks related to ensuring compliance with the facility. Facility compliance includes support related to cleaning of the facility, environmental monitoring of the facility and procedures related to gowning, flow and aseptic behavior.

The team comprise of 4 engaged colleagues that are driven by the ever-changing manufacturing pace. We strive to ensure a high quality mindset and enjoy a great team spirit.

The team operates under cGMP and are responsible for continuous facility compliance of our mammalian, microbial and adjuvant lines. With the establishment of a new facility the facility compliance will look into even more responsibility to ensure alignment across the 2 production facilities.

The team is responsible for securing the compliance framework with regards to facility compliance and environmental monitoring with emphasis on training documentation, deviations and CAPA management. 

The position

As a scientist in the Facility compliance team, you will become a specialist in the whole portfolio of task related to Facility compliance and environmental monitoring. You will be regarded as a role model and will also be responsible for:

• Owners of and responsible for continuously improving the procedures for gowning, aseptic behavior and Flow and Logistic.
• Process confirmations of above procedures
• Evaluation of current and new cleaning procedures
• Support to the manufacturing teams with tasks related to facility compliance Handling deviations
• Training of manufacturing associates
• Handling CAPA’s related to deviations
• Handling changes related to facility compliance and environmental processes
• Participate in regulatory inspections and audits
• Participate in board meetings, KPI delivery and follow-up
• Optimization and standardization of work processes related to facility compliance

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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.

Experience and competencies

The ideal candidate holds an Academic degree within science and has a strong background within facility compliance and environmental monitoring. The ideal candidate has previously been working with applied microbiology or manufacturing operating under cGMP within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences:

• 5+ years of experience from the pharmaceutical industry working in an cGMP environment
• Strong communicator
• A natural role model and coach for improving aseptic behavior
• Structured and analytically oriented
• Experience with applied Lean
• A genuine interest in being close to the manufacturing floor and understanding the need for process confirmation  

As a person you are driven by continuously improving processes and procedures. You are curious, have a good overview, is eager to learn and a team player: You thrive in a high pace environment where no two days are the same.