Work Schedule
Second Shift (Afternoons)
Environmental Conditions
Office
Job Description
Join Us as a Principal Programmer Analystt – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
The Principal Programmer Analyst serves as a senior technical and Computer System Validation (CSV) subject matter expert supporting complex and business-critical Pharmacovigilance (PV) systems and initiatives. The role leads and provides strategic oversight for validation activities associated with PV system implementations, upgrades, hot fixes, client-specific configurations, ad-hoc reports, gateway implementations, data migrations, integrations, and other system changes.
This position serves as a key validation and technical point of contact for highly complex PV projects, providing expert guidance to business stakeholders, Quality Assurance, IT, project teams, clients, vendors, and external partners. The Principal Programmer Analyst acts as a trusted consultant to the PV organization, helping ensure systems and processes remain compliant, inspection-ready, scalable, and aligned with business objectives.
The role provides expert input into project strategy, resource planning, effort estimation, risk management, and prioritization. It identifies and drives opportunities for process standardization, automation, and continuous improvement across PV system validation and associated business processes.
The Principal Programmer Analyst also champions the responsible adoption of AI, automation, and emerging technologies, identifying and implementing opportunities to improve validation efficiency, documentation quality, data analysis, testing, and overall team productivity while maintaining appropriate GxP controls and oversight.
What You'll Do
- Provide technical and validation leadership for complex, high-impact PV system implementations, upgrades, hot fixes, integrations, gateway configurations, client-specific reports, data migrations, and system enhancements. Establish appropriate validation strategies based on system complexity, intended use, regulatory impact, and risk.
- Lead requirements definition and solution assessment with business stakeholders, translating complex business and regulatory needs into clear functional and technical requirements. Provide expert review and challenge to ensure requirements are complete, testable, traceable, and appropriately translated into system design and validated solutions.
- Define and oversee risk-based validation and testing strategies for validated GxP systems. Independently plan, author, review, and execute System Integration Testing (SIT), User Acceptance Testing (UAT), Performance Qualification (PQ), and other applicable qualification and verification activities.
- Serve as a senior SME and escalation point for Computer System Validation, providing expert interpretation and application of company procedures, GxP requirements, data integrity principles, electronic records/electronic signature requirements, and applicable regulatory expectations, including 21 CFR Part 11.
- Own or provide senior oversight of validation deliverables throughout the system lifecycle, including Validation Plans, Requirements Specifications, Risk Assessments, Test Strategies and Protocols, Traceability Matrices, Validation Summary Reports, change controls, impact assessments, deviations, and other SDLC documentation.
- Apply risk-based and critical-thinking approaches to determine appropriate validation scope and level of testing, ensuring that validation activities are scientifically sound, compliant, efficient, and proportionate to patient safety, product quality, data integrity, and regulatory risk.
- Lead continuous improvement and transformation initiatives across PV systems and validation processes. Identify opportunities to simplify, standardize, automate, and optimize processes while maintaining appropriate controls and compliance.
- Champion AI-enabled innovation by evaluating and leveraging AI and automation capabilities to improve requirements analysis, risk assessment, test design, documentation, data analysis, quality review, and other validation activities. Help establish appropriate controls and ways of working for responsible use of emerging technologies within the GxP environment.
- Lead resolution of complex and cross-functional system issues, including impact assessment, investigation, root cause analysis, risk evaluation, and validation of corrective and preventive actions, system fixes, and enhancements. Provide technical and compliance guidance where issues have significant business or regulatory impact.
- Act as a strategic liaison among PV business stakeholders, Quality Assurance, IT, clients, vendors, and external partners. Influence decisions and facilitate resolution of complex technical, quality, compliance, and delivery challenges.
- Provide validation leadership within project governance, contributing to project planning, resource and effort estimates, risk management, status reviews, vendor discussions, and client meetings. Proactively identify validation risks, dependencies, and potential impacts to project milestones.
- Review and recommend improvements to procedures, standards, templates, and validation methodologies. Lead or contribute to the development and revision of SOPs, Work Instructions, technical standards, and best practices supporting validated PV systems.
- Provide technical leadership and mentorship to programmers, analysts, validation professionals, and other team members. Review complex deliverables, share best practices, support capability development, and promote consistent application of validation and quality standards across the organization.
- Lead and support regulatory inspections, client audits, and internal quality audits as a validation SME. Present validation strategies and evidence, respond to complex auditor questions, support documentation retrieval and inspection readiness, and lead or support remediation activities arising from audit or inspection observations.
- Maintain expertise in evolving regulatory expectations and industry practices, including Computer System Validation, Computer Software Assurance/risk-based assurance approaches, data integrity, Pharmacovigilance regulations, emerging technologies, and modern validation methodologies. Assess potential impacts and recommend appropriate changes to organizational practices.
- Provide strategic input into technology and process decisions, including system lifecycle planning, vendor solutions, validation approaches, automation opportunities, and future-state capabilities for PV systems.
- Perform additional responsibilities and lead strategic initiatives as required to support organizational objectives, operational excellence, compliance, and continuous quality improvement.
Education & Experience Requirements
Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
Previous experience that provides the knowledge, skills, and abilities required to perform the role, typically gained through 8+ years of relevant experience, including significant experience with Computer System Validation, regulated GxP systems, and/or Pharmacovigilance technology environments.
Experience should demonstrate increasing responsibility in leading complex validation activities, providing subject matter expertise, influencing cross-functional stakeholders, and independently resolving significant technical and compliance challenges.
Years of experience represent the typical level of related experience required to develop the knowledge, skills, and abilities necessary to perform the essential functions of the role. Years of experience should not be used as the sole determining factor in establishing job classification or making employment selection decisions.
Knowledge, Skills & Abilities
- Advanced knowledge of Computer System Validation (CSV), risk-based validation/assurance methodologies, SDLC principles, and GxP-regulated computerized systems.
- In-depth knowledge of Pharmacovigilance systems and business processes, including applicable SOPs, regulatory requirements, industry standards, and local guidelines.
- Strong understanding of applicable regulatory expectations, including GxP, 21 CFR Part 11, electronic records and electronic signatures, and data integrity principles.
- Advanced knowledge of relational database concepts and experience working with complex data systems, system integrations, interfaces, reporting solutions, and data migrations.
- Demonstrated ability to develop and critically review validation strategies, risk assessments, requirements, test approaches, traceability, and lifecycle documentation for complex systems.
- Strong analytical, critical-thinking, problem-solving, and decision-making capabilities, with the ability to assess complex technical and compliance issues and recommend practical, risk-based solutions.
- Demonstrated ability to lead complex assignments and initiatives independently, including activities involving multiple functions, clients, vendors, or geographic regions.
- Ability to influence and communicate effectively with stakeholders at multiple organizational levels and to explain complex technical and regulatory concepts clearly.
- Strong written and verbal communication skills, including proficiency in English and the ability to effectively interface with multidisciplinary teams, senior stakeholders, clients, auditors, and external partners.
- Strong organizational and project-management capabilities, with the ability to manage multiple complex assignments, competing priorities, dependencies, and challenging timelines.
- Ability to provide technical leadership, mentorship, and guidance to junior and experienced team members without requiring direct line-management responsibility.
- Demonstrated ability to identify and implement opportunities for automation, AI-enabled efficiencies, process simplification, and continuous improvement within an appropriately controlled GxP environment.
- Ability to adapt to changing business priorities, regulatory expectations, technologies, and operating models.
- Demonstrated ability to deliver high-quality outcomes within agreed timelines, project commitments, and budget expectations.
- Demonstrated commitment to collaboration, quality, continuous learning, innovation, and scientific excellence.
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.