Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing... our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global...
: *Strong engineering or "hard-science" foundation with hands-on knowledge of materials, finishes, and manufacturing trade-offs *Proven... capability, balancing cost, manufacturability, and premium quality *Working knowledge of FDA, EMA, or ISO 13485 regulatory...
the Batch Review and Release teams and the Quality Engineering/Validation team, ensuring alignment with organizational... and associated support functions such as Process Science, Engineering Science, Process Engineering, Validation, and Automation...
and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 5 years of GMP... agency regulations (such as the FDA, EMA) to ensure inspection readiness of department. Important Considerations...
At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated... Education PhD in Engineering, Biochemistry, or other biotechnology-related degree Experience Minimum of 5 years...
, electronic engineering, physics, etc). Global experience and a nuanced understanding of international regulatory landscapes..., Regulatory, and Validation Support Design validation studies following FDA, EMA, or MDR-aligned frameworks, including GCP/GCLP...
) in support of a global region (i.e., Americas, EMA or Asia/Pacific.) Organized with attention to detail. Excellent analytical... in one or two functional areas (i.e., Operations, Finance, Order Management, Procurement, Engineering, Human Resources or Payroll...
with ICH, FDA, EMA, and other global guidelines. Health Authority Interactions:Serve as the primary point of contact for CMC... within Regulatory Affairs responsible for the global regulatory strategy and execution related to the pharmaceutical quality...
-5pm 100% on-site (Madison, WI) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization... (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing...
digital innovation for QC laboratory Minimum Requirements/Qualifications: BS in Science, Engineering, or a related field... plus 10+ years of experience, 7 of which should be in a management role Knowledge of FDA, EMA, CFDA, PDA Regulations...