Senior Validation Analyst

Southern Research•Birmingham, AL

10h•Hybrid

About The Position

The Senior Validation Analyst leads strategic validation initiatives to introduce new GxP technologies at Southern Research. From technology assessment and procurement through planning, validation, operational support, and eventual retirement, this role owns validation deliverables and ensures systems remain in a validated state throughout their lifecycle. This position collaborates with the Business, Application Administrators, Information Technology, and internal Quality teams at Southern Research to define standard business processes and requirements. Using that information, they author and/or review the validation deliverables required to implement these technologies in a GxP environment. This includes leading any testing efforts required to demonstrate the system is fit for use. This role requires strong knowledge of regulatory requirements and guidance (e.g., 21 CFR Part 11, 21 CFR Part 58, EU Annex 11, GAMP) and the ability to think strategically while managing multiple concurrent initiatives.

Requirements

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.

Nice To Haves

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.

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.