Manufacturing Engineer
ArdenaHighlight
Summary
About the Role
About You
- Bachelor's degree in Chemical, Mechanical, Industrial, or Manufacturing Engineering.
- 2-5+ years of experience in pharmaceutical, chemical, or other regulated GMP manufacturing environments.
- Strong knowledge of cGMP, validation practices, and regulatory expectations (FDA/EMA/ICH).
- Proficiency in statistical analysis, including SPC, control charting, trend evaluation, and process capability.
- Experience with granulators, mixers, tablet presses, chemical reactors, extruders, or packaging lines.
- Lean/Six Sigma experience.
- Hands-on experience with statistical software such as Minitab, JMP, or equivalent tools.
- Automation, SCADA, or MES experience.
Benefits
- A competitive salary with a tailor-made benefits package, including medical, dental and vision benefits effective day one of employment.
- Paid Time Off.
- A dynamic, global work environment with career growth opportunities.
- Access to Ardena Academy, our internal learning platform for professional development.
- A chance to contribute to groundbreaking drug development projects that make a real impact.
We are a global provider of drug development and discovery services, encompassing drug substance, drug product, bioanalysis, and CMC regulatory services across small molecules, large molecules, and nanomedicines. Our six international locations offer comprehensive CDMO and BioAnalytical CRO services to a wide range of clients worldwide. We recognize the intricate challenges associated with advancing a promising molecule from the laboratory to the patient. Our multidisciplinary team is eager to collaborate with you throughout your development process, utilizing specialized technologies to optimize formulation and manufacturing. We possess extensive expertise in spray drying, hot melt extrusion, and lipid-based formulations that enhance bioavailability and solubility. Additionally, our capabilities include polymeric, metal, and lipid nanoparticles for advanced drug delivery applications, as well as high-potency and controlled substance handling for highly specialized therapeutics. At Ardena, all work adheres to the appropriate regulatory standards as you progress through the clinical development pathway. Please contact us to further discuss your clinical and scientific objectives and explore how we can work together.