Process Engineering Specialist, Purification

Just is seeking a highly motivated and creative purification Process Engineer who desires a significant opportunity to improve worldwide access to biotherapeutics. The new Engineer will join a fast-paced, collaborative, and multidisciplinary team responsible for the manufacture of mammalian cell-based biotherapeutics for clinical use. The focus of this job is to guide the execution of manufacturing operations while ensuring cGMP compliance, provide project leadership as a lead or technical resource, and to develop, assess and implement disposable-based manufacturing technologies. This position may supervise others and requires a significant on the floor presence. Additional job responsibilities may include troubleshooting and/or providing technical expertise to perform or lead investigations, ensuring staff training compliance, developing and maintaining manufacturing and technical documentation. The staff member may also lead aspects of technical operations and technology transfer; act as a functional lead for new product introduction; participate or lead the evaluation of new manufacturing technologies; and participate/provide key input to multidisciplinary project/technical teams. As a key senior member of the downstream group, the successful candidate will be highly knowledgeable regarding chromatography and filtration methods and have significant experience executing these methods at large scale.

Qualifications and Education Requirements:
•Bachelor’s degree in biological or engineering science with 5-10+ years relevant experience
•Significant experience in the purification operations required for the manufacture of biotherapeutics
•Candidate must possess strong focus on quality and attention to detail
•Possess effective task/time management organizational skills
•Capacity to develop solutions to technical issues of moderate scope
•Ability to organize, analyze/interpret, and effectively communicate results
•Motivated, self-starter with strong mechanical aptitude
•Good interpersonal, team, and communication skills are a must
•Excellent oral and written communication skills

Preferred Qualifications:
•In-depth knowledge of purification equipment, operations, and engineering principles
•Subject matter expert in large scale downstream unit operations including column packing, chromatography operations, dead end filtration, viral filtration, and TFF
•Recognized technical mastery of disposable manufacturing technologies from bench-scale through commercial scale
•Proven knowledge of cGMP requirements to ensure compliance
•Change control, NC/CAPA, and deviations
•Fundamental understanding and basic operation of process automation (DeltaV)
•Experienced in technology and/or process transfer for late-stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus
•Experience applying knowledge and expertise to solve complex technical problems; may apply novel approaches that provides significant technology advancement
•Ability to work independently and/or manage the activities of individuals, work group, or project teams; experience as a significant contributor to multi-disciplinary teams at the functional level; mentoring and providing technical advice to individuals within the team
•Experience as an active participant/lead in technical projects with collaborators and vendors

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