Senior Manufacturing Systems Analyst

Summary:

We are looking for a Senior Manufacturing Systems Analyst to define, document, and manage systems for manufacturing or CMC teams within Vaxcyte's IT team. The candidate should be proficient in MES or similar software used in vaccine development, have strong skills in requirement analysis, coordination with cross-functional teams, and implementation of complex systems following industry standards. This role involves aligning business needs with technical solutions to support operational efficiency and innovation in scientific work. 

Essential Functions:

• Understand the manufacturing process of vaccines and lead the requirements gathering process, working closely with stakeholders to define business needs and translate them into clear, actionable requirements. 
• Develop detailed functional and technical specifications, ensuring alignment with regulatory requirements and organizational goals. 
• Act as the main liaison between business users, technical teams, and external vendors, ensuring all parties are aligned on project objectives and timelines. 
• Drive cross-functional collaboration, ensuring that requirements are understood and addressed across all relevant teams, including development, quality assurance, and operations. 
• Collaborate with product and system owners to prioritize and manage the requirements backlog, ensuring timely delivery of features and functionalities. 
• Analyze and document business processes, identifying areas for improvement and recommending solutions. 
• Provide technical support in translating requirements into system designs and configurations. 
•  Coordinate with QA and validation teams to ensure that all requirements are fully tested and validated according to industry standards. 
• Monitor progress, manage change requests, and ensure requirements are properly tracked and maintained throughout the project lifecycle. 
•  Provide training and support to internal teams and end users on new system functionalities and enhancements. 

Requirements: 

• Minimum 7 years of experience with preferred experience in Life Sciences or other regulated industry. Other combinations of education and/or experience may be considered. 
• Proficiency with Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS) and Aveva PI data historian. 
• Hands-on experience creating use case diagrams, system architecture and boundary diagrams, and process and data flow diagrams. 
• Proficient in SQL and relational database knowledge and experience modeling and creating ERD diagrams. 
• Strong knowledge of business analysis techniques and tools, including process mapping, requirements documentation, and traceability. 
• Proficiency in requirements management software and methodologies (e.g., Enterprise Architect, UML). 
• Strong communication skills with experience in creating clear documentation and presentations for both technical and non-technical stakeholders. 
• Experience in working with cross-functional teams in regulated environments, ensuring compliance with industry standards and best practices. 
• Strong problem-solving and analytical skills, with a keen ability to break down complex business needs into clear and actionable requirements. 
• Experience with system validation processes and knowledge of creating and reviewing validation documentation. 
• Ability to manage multiple projects and priorities, ensuring timely and efficient delivery of solutions. 
• Preferred Qualifications: 
• Certificate or training in Sparx Systems Enterprise Architect software.  
• Knowledge of programming languages such as Python or similar experience in agile project management methodologies and tools. 
• Experience with cloud-based solutions and platforms.