Technician for QC Microbiology, Environmental Monitoring

Job description

Are you looking for an opportunity to kick-start your career in an international and inspiring global manufacturing environment? Now is your chance to become a part of our dedicated QC department and Microbiology team, as a Technician working with environmental monitoring (EM)! Join a big & dedicated QC department with great colleagues! Quality Control (QC) at AGC Biologics consists of QC Bioassay, QC Chemistry, QC Microbiology, QC Raw Materials, and QC Stability. You will be joining QC Microbiology, consisting of 17 dedicated (laboratory) Technicians and 10 Scientists. We are responsible for microbiological method validation, analysis of production samples for both clinical trials and commercial drug substance manufacturing, environmental monitoring (EM) of production areas, chemical and microbiological testing of pharmaceutical water, and TOC analysis of cleaning samples from production equipment. Our department is organized into two sub-departments: the Microbiology Laboratory and Environmental Monitoring (EM). In the EM team, we are responsible for monitoring our classified cleanrooms (Grade B, C, and D) and our tasks include particle counting, airborne microbial monitoring, contact plates, glove prints, and more. In addition, the department is responsible for sampling and testing of gas and water systems. Learn & grown in Environmental Monitoring As a Technician in QC EM, you will be responsible for performing environmental monitoring sampling (EM and water) and analyzing these samples. You will also assist with administrative tasks such as updating SOPs, creating samples in LIMS, and reviewing EM data. Through EM and microbiological testing of production rooms and products, you will help ensure compliance with cleanroom environmental requirements and verify that manufactured products meet the expected microbiological quality standards. You will also have opportunities to participate in investigations, provide support, and follow up on corrective and preventive actions related to microbial environmental and product excursions, in collaboration with development and production departments. Join our team and be part of an exciting journey building a good flow in our new manufacturing facility! We are looking for a colleague who takes initiative and responsibility! We expect that you have a relevant educational background and experience from the pharmaceutical industry. Preferably you have professional experience within microbiology or EM from a QC or manufacturing department, since the role is combining some degree of lab work with a close and daily collaboration with manufacturing. It is a requirement to have experience and understanding of working under GMP regulations. With this we hope t hat you bring an analytical mindset and structured approach, a good overview of multiple tasks and coordination of priorities. We offer a great amount of trust, and expect that you show great responsibility and flexibility to changes. "In our team we highly value your input and acknowledge your contributions. We hope to get a new colleague, who likes to take initiative and responsibility - we will offer you great room to learn and grow - together!" - Thomas Winckelmann, Team leader, WC Microbiology In addition, the following qualifications are considered an advantage: Experience with aseptic behavior and practices Experience with environmental monitoring in classified areas Experience with LabWare LIMS Strong quality mindset and experience reviewing/approving data On the personal side, our team has a positive team spirit and is good at collaborating between all our Technicians and Scientists, so we expect you to tap well into this teamwork. We believe that we have a good sense of humor and welcome any great sense of humor to our team! We all need the ability to plan and complete work independently, efficiently, and on time while maintaining high quality, so this approach from you will be highly appreciated. All our procedures are written in English, so having strong written and verbal communication skills in both Danish and English will help you succeed in this role. It is a requirement for this job to be part of the weekend shift schedule, currently with a shift approximately once a month. Your application & our recruitment process Apply today with a motivated CV and no later than Sunday August 9. Applications will be reviewed on an ongoing basis, and qualified candidates will be invited for interviews continuously, aiming to find the right candidate by the end of August. We aim for a start date as soon as possible, preferably on October 1. Who We Are AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.