IT Business Analyst, GMP Systems

Just-Evotec Biologics is seeking a highly motivated and innovative IT Business Analyst to join a fast-paced, collaborative, and multidisciplinary team focused on changing the Biotech industry for the better. The individual in this position will partner with the Manufacturing and Supply Chain functions to implement new GMP systems such as Werum PAS-X (MES), Maximo (CCMS), and ERP into our new state of the art J.POD biotech manufacturing facility. This position will provide System Ownership responsibilities that range from requirements gathering, implementation and configuration to Validation and maintenance activities.

Responsibilities:

• Provide technical and application administration of Just-Evotec's manufacturing and supply chain systems.
• Create and maintain a technology roadmap in line with business goals
• Maintain the compliance of supported systems throughout their lifecycle in line with CFR 21 Part 11 regulations and Data Integrity best practices.
• Provide end user support and training.
• Integrate Data Integrity into system design and business processes.
• Suggest and implement modifications to technical configurations and business processes to achieve a robust and compliant system.

Qualifications and Education Requirements:

• Bachelor's Degree (Computer Science, Information Systems, Engineering, etc.).
• 3+ years of work experience as a Business or Systems Analyst implementing and/or supporting IT systems, technologies, and platforms within regulated industries.
• Must have experience implementing and supporting GMP systems as well as familiarity with CFR 21 Part 11 and Data Integrity requirements.
• Strong Knowledge of operations technology Systems Development Life Cycle, application development, or systems integration with 3+ years of experience in a regulated environment.

Preferred Qualifications

The ideal candidate will have experience in one or more of the following:

• Assist in creation of project plans and timelines, define project deliverables, identify and track issues and their resolutions.
• Validation of computer systems for use in a Good Manufacturing Practices (GMP) environment and creating and revising Standard Operating Procedures (SOPs)
• Conduct knowledge transfer and training of end-users, including sharing best practices.

About Just - Evotec Biologics

Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 200 employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers