Facility Compliance Scientist

at  AGC Biologics

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
About the Team and Department
The Facility Compliance team supports all manufacturing departments with tasks related to ensuring facility compliance. This includes cleaning the facility, environmental monitoring, and procedures related to gowning, flow, and aseptic behavior.
The team comprises seven dedicated colleagues (you will be the seventh) and one team leader driven by the dynamic pace of manufacturing. We strive to maintain a high-quality mindset and foster an effective team spirit.
Operating under cGMP, the team is responsible for continuous facility compliance for our mammalian, microbial, and adjuvant lines. With the establishment of a new facility, the Facility Compliance team will take on additional responsibilities to ensure alignment across both production facilities.
Our team secures the compliance framework for cleanroom facility compliance and environmental monitoring, focusing on SOPs, training documentation, deviations, and CAPA management.
About the Role

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

• Owning and continuously improving procedures for gowning, aseptic behavior, flow, and logistics.
• Conducting process confirmations of these procedures.
• Evaluating current and new cleaning procedures.
• Supporting manufacturing teams with facility compliance tasks, including handling deviations.
• Training manufacturing associates.
• Managing CAPAs related to deviations.
• Handling changes related to facility compliance and EM processes.
• Participating in regulatory inspections and audits.
• Participating in board meetings, KPI delivery, and follow-up.
• Optimizing and standardizing work processes related to facility compliance.

Your Profile

The ideal candidate holds an academic degree in science and has a strong background in facility compliance and environmental monitoring. Previous experience with applied microbiology or manufacturing under cGMP in the pharmaceutical industry is highly valued. The ideal candidate should possess several of the following competencies and experiences:

• Professional experience in the pharmaceutical industry working in a cGMP environment.
• Strong communication skills.
• 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 the continuous improvement of processes and procedures. You are curious, have a good overview, are eager to learn, and value being a team player. You thrive in a high-paced environment where no two days are the same.

How to Apply

• To apply, please submit your CV. We encourage you to apply, even if you do not meet every requirement.
• If we see a potential match, one of our recruiters will contact you to discuss your application.
• If both sides remain positive after this discussion, we will move forward to the assessment stage to evaluate the key skills required for the job.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on
LinkedIn and give us a quick Like on
Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

• Owning and continuously improving procedures for gowning, aseptic behavior, flow, and logistics.
• Conducting process confirmations of these procedures.
• Evaluating current and new cleaning procedures.
• Supporting manufacturing teams with facility compliance tasks, including handling deviations.
• Training manufacturing associates.
• Managing CAPAs related to deviations.
• Handling changes related to facility compliance and EM processes.
• Participating in regulatory inspections and audits.
• Participating in board meetings, KPI delivery, and follow-up.
• Optimizing and standardizing work processes related to facility compliance