Scientific Systems Analyst

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Position Summary

This position assumes a key function in achieving the deliverables for Data Excellence set for the Vaccine R&D Clinical Immunology group at Emergent Travel Health San Diego. This position is part of a team dedicated to the development, qualification, and validation of pre-clinical and clinical biological assays with primary focus on virus neutralization assay testing of clinical samples. The role is responsible for supporting the design, validation, implementation, and maintenance of computerized systems aimed at capturing and managing data involved in compliant GCLP activities. The role works closely with, and reports to, the Clinical Immunology Senior Manager of Data Excellence to ensure timely delivery of project specific demands and requirements. A quality-driven mindset with a relentless drive for continuous improvement is a must.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Support the design, validation and implementation of computerized systems to ensure that they comply with applicable regulations, international standards, and industry best practices.
• Write technical documents including specifications, risk assessments, protocols, tests, plans and reports to establish and maintain the validated state of computerized systems throughout their lifecycle.
• Verify and implement specifications and procedures for computerized administration of software and laboratory instrumentation (requires on site work).
• In conjunction with the calibration and validation department, ensure that equipment and processes maintain their compliant state throughout their lifecycle, in line with regulatory agencies including the FDA.
• Design business processes that are scientifically sound, compliant and conform with the highest standards for data integrity.
• Assist in resolving data quality problems through the appropriate choice of error detection and correction, process control and improvement, or process design strategies.
• Drive continuous improvement efforts to increase efficiency and data integrity outcomes.
• Develop, monitor, and enforce data management policies, procedures, and standards.
• Interact productively and efficiently with QA, IT, the validation and calibration department, and the laboratory safety department.
• Participate in data review activities to ensure accuracy, consistency, and reliability of data.
• Support custom database design, programming, validation, and maintenance in support of laboratory operations.
• Provide support for the completion of quality processes including change requests, deviations and CAPAs.
• Provide validation and data integrity advice and guidance to other teams, as needed.
• Stay abreast of the latest guidance documents and industry best practices.
• Represent Clinical Immunology during regulatory agency inspections and customer audits.

Minimum Education, Experience and Skills

• Bachelor's or Masters' Degree in an applied science (Engineering, Computer science or related scientific field).
• Bachelor's degree with minimum 4 years / Master's with minimum 2 years in an FDA-regulated industry in the area of computerized system validation.
• Experience with one or more of the following languages is a plus: SAS, SQL, VBA, R, JMP.
• Experience with Agile software development is a plus.

• Demonstrated strong knowledge of validation principles and concepts including CSV/GAMP5, 21 CFR Part 11, Annex 11, Project Life Cycle and quality systems, GxP, GDP and FDA/EMEA guidelines and proven ability to apply guidelines to all aspects of validation activities.
• Strong knowledge of engineering and related practices, including regulations and guidances such as PIC/S, ISPE, EMA, FDA.

• Excellent organizational, analytical and problem-solving skills.
• A continuous improvement mindset is a must.
• Strong technical writing skills.
• Excellent interpersonal and collaboration skills.

• Demonstrated ability to manage complex validation projects in a fast-paced environment is required.
• Ability to function with minimal supervision and as part of a cross-functional team of professionals.
• Demonstrated technical proficiency, creativity, and independent thought.
• Ability to make decisions exercising good judgment within generally defined practices and policies.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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