The Pharmaceutical Quality Engineer is a technical professional that participates in the development, implementation, and evaluation of processes, procedures, and applications with the overall objective of ensuring quality of product and process inputs and outputs, as well as compliance with quality practices by production personnel.
At Clene Nanomedicine, the Pharmaceutical Quality Engineer will work directly with colleagues who have developed novel production processes for aqueous metallic nanoparticles as an Investigation New Drug. The Engineer will use engineering, scientific, and regulatory knowledge, as well as evidence grounded in demonstrable data, to resolve a wide range of complex issues. The Engineer will demonstrate that processes remain in control and develop systems to allow other personnel to do the same, through training, process design and development, and implementation of GxP quality principles.
The Pharmaceutical Quality Engineer reports to the Director of Quality Engineering.
. 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.