Southern Research · 11 hours ago
Senior Validation Analyst
Greater Birmingham, Alabama Area
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expSouthern Research has been translating science into real-world solutions since 1941. The Senior Validation Analyst leads strategic validation initiatives to introduce new GxP technologies, ensuring systems remain in a validated state throughout their lifecycle while collaborating with various teams to define processes and requirements.
BiotechnologyLife ScienceOncology
No H1B
Responsibilities
Build Technology Assessment: Partner with the business, IT, and others to identify technologies suitable for the intended purpose within a GxP environment
Validation and Project Management: Lead system validation efforts, including validation strategy, risk management approach, and overall validation project management
Develop and maintaining validation deliverables including, but not limited to: Validation Plan, User Requirements Specification, Configuration Specification, Testing Strategy, Test Scripts with Traceability, Validation Summary Reports, and System Commissioning documents
Develop business scenarios to test applications
Operational Lifecyle: Support the validated state of applications or systems via change management and Periodic Review activities
Document analysis and/or testing related to infrastructure changes. (e.g., operating system patches, significant network changes)
Create or update to application specific documentation (e.g., requirements, Configuration Specification…) to match the evolution of the system
Incident Management and Investigation: Investigate incidents observed during validation; identify root causes, corrective actions, and appropriate controls
Support Application Administration to investigate incidents observed in production
Continuous Improvement and Retirement: Perform gap assessments and drive process/continuous initiatives
Identify technologies no longer required and lead the retirement activities
Communication, Stakeholder Support & Escalation: Troubleshoot, collaborate, and communicate technical issues and resolutions to users, department managers, and other stakeholders
Escalate issues to management, communication, and work with application/system vendors as necessary
Audit & Inspection Readiness: Maintain a high-level of validation and business acumen in addition to regulation and industry best practice
Track, coordinate, and review user access reviews and other periodic review activities
Represent validation efforts in client and regulatory audits. Contribute to audit finding responses as necessary
Identify, contribute, and/or lead the development or refinement of validation policies and procedures
Cross Functional Partnership: Establish and maintain open communication between the Business, Information Technology and Quality
Triage escalation of validation and/or technical issues to Information Systems and Management
Lead or support process improvement initiatives as necessary
Qualification
Required
Bachelor's degree in computer science or life sciences, other related field, or equivalent experience
8+ years of experience within a Quality or Technical role (e.g., IT) with direct experience leading validation efforts
Experience with the validation, administration, operation, and/or maintenance of Laboratory Information Management Systems (LIMS) and other computerized systems used in a GxP laboratory/environment (e.g., Chromatography Data Systems, Spectrophotometry Systems, cell counting/viability systems)
Advanced knowledge of pharmaceutical/CRO industry regulations, standards, and guidelines (GxP, CSV, 21 CFR Part 11 and EU Annex 11)
Client focused approach with the strong interpersonal skills
Strong attention to detail and the ability to learn new computer systems with minimum instruction
Advanced organizational skills and the ability to manage projects independently. Ability to produce high quality results while working under the pressure of strict deadline
Ability to multi-task and participate in multiple projects and department initiatives concurrently
Ability to function effectively independently, as necessary, and work with others to achieve team goals
Preferred
Extensive experience validating and supporting Enterprise systems such as: Veeva Quality, Provantis, Benchling, and Elemental Machines
Experience validating laboratory systems such as SoftMax Pro, MSD Discovery Workbench, QuantStudio, and/or Analyst
Specific Pharmaceutical or CRO industry experience
Benefits
Medical
Dental
Vision
401(k) match
Life insurance
PTO
An employee assistance program
Company
Southern Research
A non-profit biomedical sciences research organization specializing in oncology, infectious disease, and neuroscience.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$9.89MKey Investors
US Department of Commerce, Economic Development AdministationU.S. Environmental Protection AgencyUS Department of Energy
2023-11-09Grant· $0.75M
2023-10-23Grant· $0.44M
2019-10-14Grant· $2.8M
Leadership Team
Josh Carpenter
President and CEO
Daniel Ryan
Chief Operating Officer - Venn Labs
Recent News
EIN Presswire
2025-08-06
Seattle TechFlash
2025-03-14
Birmingham Business Journal
2025-01-14
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