Materials Process Engineer I/II – Manufacturing Technical Operations
Just is seeking a highly motivated Materials Engineer in the Manufacturing Technical Operations group that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to work with operations to develop, procure, commission and test single use assemblies and manifolds for our flexible manufacturing facilities. Candidate will coordinate with supply groups to bring components into the facility and with the Quality group to develop operating procedures and specifications for the materials. In addition, the candidate will be responsible for supporting the evaluation and introduction of new single use manufacturing technologies, including assessments of leachables and extractables, and assisting with the commissioning and validation of new process equipment in the facility.
•Bachelor’s degree in engineering science or related program with 1-3 years relevant experience.
•Experience designing and developing single use components for commercial manufacturing equipment.
•Materials science background and understanding of chemical compatibility, and leachables / extractables profiles of single-use components
•Understanding of process equipment such as single use bioreactors, chromatography and filtration processing equipment and operations used to manufacture biotherapeutics.
•Proven knowledge of cGMP requirements and experience with single use flow path operations and disposable-based manufacturing technologies from bench-scale through commercial scale.
•Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills.
•Ability to organize, analyze/interpret, and effectively communicate process data.
•Good interpersonal, team, and collaborative skills are a must.
•Excellent oral and technical writing communication skills.
Additional Preferred Qualifications:
•Applies knowledge to solve complex technical problems; may apply novel approach that provides significant technology advancement.
•Can work independently and in project teams.
•Experience with equipment commissioning/validation activities a plus