Working with Manufacturing and Research and Development, ensuring that all mechanical and electrical systems supporting manufacturing activities, operate as designed to provide the highest level of customer service while minimizing work in process and finished goods inventories.
In addition, provide front line support for technicians through hands- on training, activity oversight when needed, and ensuring compliance to GMPs and company guidelines.
. Requirements:
Essential Duties and Responsibilities
Analyze and optimize processesDesign and conduct experimentsManage and interpret dataEvaluate and select equipment, materials, and suppliesContribute to regulatory submissions and patentsApplies and follows industry standards such as cGxP, ICH, and/or FDA Guidance for IndustryReports to supervisor and issues that may affect identity, strength, quality, and purity of productsAuthors specifications, SOPs, batch records, protocols for studies, processes, products, and quality programsSupports quality audits, inspections, and investigationsPreforms review of quality documents, such as equipment logs, training records, test results, batch records, and supporting documentsDevelop and/or implement engineering and quality policies, tools, methods, and trainingProvide authoritative guidance and advice to management, customers, and teammates in functional areas of expertiseWorks across functional lines facilitating team projects to resolve complex problems, and implement process, quality, and compliance improvements
Specific Duties
Knowledge of, or experience with, the following technologies and processes in an FDA regulated environment (or equivalent, e.g. EMA)
Water treatment, purification, and filtrationClean roomsTransverse flow filtration concentrationFilter integrity testingMicrobiological monitoring and controlsAseptic techniqueMethods of sterilizationCleaning and sanitization processesStandard operating procedures, validation / qualifications, reports, internal audits, technical investigationsMaterials evaluation and qualificationPhysicochemical properties of nanoparticles and metallic nanoparticles
Education and/or Experience
Bachelor’s degree or equivalent in engineering, scientific, or technical discipline; and/or three to five plus years related experience and/training; or an equivalent combination of education and experience in the pharmaceutical industry.