Compliance Specialist
1 month ago
We are seeking a highly skilled Compliance Engineer to join our Plant Engineering department at AGC Biologics. As a Compliance Engineer, you will play a critical role in ensuring that our facilities and systems meet the highest standards of quality and compliance.
Key Responsibilities- Collaborate with colleagues and stakeholders to maintain compliance with regulatory requirements
- Handle quality documents such as deviations, change controls, CAPAs, and procedure updates
- Familiarize yourself with technical systems to manage tasks independently
- Contribute to the continuous improvement of our utilities, facilities, and systems
- Present documentation during audits and inspections
- Relevant technical background as an engineer or equivalent technical experience in the pharmaceutical or process industry
- Knowledge of GMP is preferable, along with experience in operations, maintenance, or project participation
- Passion for working with quality-related documentation
- Pragmatic and flexible approach with a strong focus on achieving goals
- Good communication skills, including the ability to communicate clearly in both written and spoken English and Danish
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. 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.
We are an equal opportunity employer and welcome applications from diverse candidates. Our core values are Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork. We offer a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.
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