Specialist Manufacturing 35451

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.

• Experience of bio-processing unit operations
• 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/Tools: Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms
• Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish
• Teamwork Oriented
• Able to work under minimal supervision and/or high workload and pressure
• Able to work extended hours
• Excellent interpersonal skills

• Doctorate, or a Master's degree with 2 years of Manufacturing Operations experience, a Bachelor's degree with 4 years of Manufacturing Operations experience, an Associate's degree with 8 years of Manufacturing Operations experience, or a High school/GED with 10 years of Manufacturing Operations experience.
• Preferred academic background in Life Sciences, Engineering, Biotechnology, Chemistry, and/or Engineering