Specialist Manufacturing 35596

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

• In-depth experience of bio-processing unit operations (Cell Culture, Drug Substance Purification)
• Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe)
• Familiar with Lean Manufacturing Practices
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Proficiency in GDP (Good Documentation Practices) on a regulated environment
  
• Knowledge in systems: Trackwise, Spotfire, CDOCS, and process monitoring platforms
• Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish

• →Doctorate OR Master’s + 2 years of Manufacturing Operations experience OR Bachelors + 4 years of Manufacturing Operations experience OR Associates + 8 years of Manufacturing Operations experience OR High school/GED + 10 years of Manufacturing Operations experience