POSITION OBJECTIVE: Independently develops, supports, and validates aseptic and sterile manufacturing processes in a GMP environment. Scope may include: design, specification, evaluation, installation, and qualification of equipment and new technologies for reliable, cost effective aseptic and sterile production systems. May guide and train less experienced maintenance/operations personnel on the use of manufacturing equipment and/or processes.
Essential Job Functions/Responsibilities
· Develop and validate aseptic manufacturing processes, both manual and automated.
· Troubleshoot existing processes and recommend or design engineering solutions and/or equipment to address quality, capacity, and robustness issues.
· Apply engineering principles to amend, model or prototype new and existing processes and develop specifications for critical parameters.
· Monitor and collect data regarding system/equipment performance and report. Identify existing problems and recommend solutions.
· Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
· Drafts detailed drawings or sketches of components and/or systems used for the improvement of manufacturing equipment.
· Trains maintenance/operations staff on troubleshooting techniques and use of manufacturing equipment.
· Interface, collaborate, and communicate with internal customers and cross-functional teams on productivity projects and cost saving measures.
· Conducts routine validation and qualification protocols for new and existing equipment. Follow good documentation practices. Understand qualification of equipment in a GMP environment
· May perform other related duties as required and/or assigned.
Required Education & Qualifications
· Understand aseptic processing validation: media fill validations, good aseptic techniques, capable of training production personnel on good aseptic technique.
· Bachelor’s degree in an engineering or scientific discipline (e.g., biochemistry)
· Requires 5 or more years engineering or relevant experience. Thorough working knowledge of relevant manufacturing systems and processes required. Experience in a GMP manufacturing.
· Experience in lean manufacturing and six sigma.
· Solid communication and problem solving skills required. Experience in participating or leading root cause analysis
· Proficiency in the use of Excel, Word, statistical software programs.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.