Senior Validation Analyst - Birmingham - Southern Research

Description

Overview

Southern Research + You Discover a career where your work truly matters. Southern Research has been translating science into real-world solutions since 1941. Join our innovative team and enjoy benefits like medical, dental, vision, 401(k) match, life insurance, PTO, an employee assistance program, and more.

General Summary 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.

Essential Duties & 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 maintain 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 Lifecycle

• 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 improvement initiatives.
• Identify technologies no longer required and lead 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 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.

Requirements / Minimum Qualifications

• 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 Qualifications

• 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.

Core Values

Cultivating human connection – putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world's most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of thought go hand in hand. We understand that relationships move at the speed of trust.

Operating with precise execution – measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing.

Harnessing relentless curiosity – our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results.

Stewarding a healthy community – implementing sustainable operations for a safe, engaging environment. We don't compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked.

Job Specific Behaviors

Relationship Orientation – Develops positive relationships by making others feel their concerns and contributions are important.

Continuous Learning – Proactively seeks performance feedback and identifies approaches to improve personal and others performance and learning.

Tolerance for Stress, Ambiguity & Change – Demonstrates flexibility in applying different approaches to changing work demands.

Effective Communication – Creates a team environment in which information flows freely and decision making is based on a win-win philosophy.

Customer Focus – Responds to customer's needs in a manner that provides added value and generates significant customer satisfaction.

Compliance – Applies an understanding of legal precedents, policies and practices to protect the interests of the organization.

Cross-team Collaboration – Ensures integration and cooperation across organizational boundaries.

Service Development, Delivery, Refinement and Quality – Manages service delivery to ensure high levels of customer impact and satisfaction. Constantly focuses on the continuous improvement of services and processes.

Physical Demands

This position primarily requires working in an office setting using a computer for extended periods. Occasional travel to Birmingham, AL if working remotely.

Work Authorization

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Equal Employment Opportunity Statement

Southern Research is committed to providing equal employment opportunities to all individuals, regardless of race, color, national origin, ancestry, gender, sex, age, disability, religion, sexual orientation, gender identity, genetic information, veteran status, or any other characteristic protected by federal, state, or local laws.

We are an equal opportunity employer and seek to create a diverse and inclusive workplace. Our hiring, training, promotion, and compensation practices are based on the principles of fairness, equality, and merit.

Southern Research prohibits discrimination or harassment of any kind, including harassment based on any protected characteristic. We are committed to maintaining a work environment where all individuals are treated with respect, dignity, and fairness.

In addition, we provide reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act (ADA) and applicable state laws. We also offer support for individuals who require accommodations due to religious practices or beliefs.

If you have any concerns about discrimination or harassment, please contact immediately. We are committed to investigating all concerns thoroughly and promptly and taking appropriate corrective action when necessary.