Manufacturing professional with expertise in GMP operations, CAPA, RCA, process improvement, technical writing, compliance, and team collaboration.
30th June, 2026
SUMMARY
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.
FUNCTIONS
Applied Process Expertise
Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
Provide troubleshooting support.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
REQUIREMENTS
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
Preferred:Educational background in Life Sciences, Biology, Chemistry, and/or Engineering.
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