Associate Principal Validation Scientist Full-time

Associate Principal Validation Scientist

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50' Business in Frederick and awarded Frederick County's 'Best Place to Work'. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we take time to recognize our achievements and celebrate our diversity. We are dedicated to creating a culture of inclusion and collaboration and are committed to continuous learning by offering ongoing skill building and training for our staff. Fueled by our aspiration to deliver accelerated growth for our company and to make people's lives better, there's never been a more exciting time to join the team and shape the future of AstraZeneca Operations.

The Associate Principal Validation Scientist is a senior technical leader responsible for validation strategy, governance, and lifecycle execution for computerized manufacturing systems including Process Control Systems (PCS), automation platforms, historian infrastructure, and Manufacturing Execution Systems (MES) within a GMP-regulated biopharmaceutical manufacturing environment.

This role provides deep technical leadership in computerized system validation (CSV), automation system compliance, and digital system reliability to support safe, compliant, and efficient manufacturing operations. The Associate Principal leads validation planning and execution for complex systems, supports automation and control system integration across manufacturing platforms, and ensures digital systems meet regulatory expectations including 21 CFR Part 11, Annex 11, and GAMP 5 principles.

Accountabilities:

• Validation Strategy & Execution: Lead validation lifecycle activities (planning, specification, testing, and reporting) for computerized manufacturing systems including process control systems, historian platforms, MES, and automation infrastructure. Develop and execute validation strategies aligned with regulatory expectations and risk-based validation approaches, such as Computer Software Assurance (CSA). Author validation plans, specifications, traceability matrices, and validation reports for complex GxP systems.
• Automation & Process Control Systems: Provide technical leadership for validation and lifecycle management of process control systems and automation platforms supporting manufacturing operations. Support integration of automation, historian, MES, and enterprise systems across the manufacturing control architecture while ensuring compliance with regulatory requirements. Partner with process engineers and manufacturing operations teams to ensure reliable, compliant operation of control systems supporting production processes.
• Computerized Systems Governance: Establish and maintain best practices for computerized system validation and lifecycle management. Support validation governance, inspection readiness, and compliance alignment across site computerized manufacturing systems. Oversee validation testing tools and repositories (e.g., HP ALM) and ensure documentation standards are maintained.
• Operational Technology & Manufacturing Support: Provide technical expertise supporting troubleshooting, deviation investigations, and change control implementation involving digital manufacturing systems. Evaluate system changes and technical impacts on validated state and manufacturing operations.
• Digital Tools & Data Science: Design and implement data visualization tools and dashboards using Power BI and related platforms to support validation oversight and operational visibility. Develop automation tools and workflows using Power Apps, Power Automate, and Python. Support data-driven decision-making through development of automated reporting, data collection tools, and process monitoring dashboards.
• Change Control, Deviations & Risk-Based CSV: Lead technical assessments for change controls, support regulatory communications related to system changes, and lead deviation investigations and CAPA planning for computerized systems.
• Continuous Improvement & Technical Delivery: Lead and influence transformation and continuous improvement initiatives (Lean/Six Sigma) to drive quality, efficiency and cost savings; contribute as a technical expert to site projects, capital scopes and MES/automation deployments.
• Strategic Validation & Digital Roadmap: Define and drive validation, digital and MES roadmaps aligned to site and enterprise objectives; anticipate system/process risks, recommend mitigations and influence investment decisions.
• Data Analysis & Performance Monitoring: Collect, organize and analyze data within Technical Operations Engineering and MES domains to identify trends, monitor KPIs, and propose implementable corrective and improvement actions; develop dashboards for operational and quality metrics.
• Project, Budget & Resource Management: Track budget, progress and resource coordination for engineering and validation operations within own process area; proactively manage timelines and coordinate cross-functional teams and external vendors to deliver technical solutions on time.
• Stakeholder & Regulatory Engagement: Build and maintain relationships with key internal clients, portfolio managers and cross-site stakeholders; represent Technical Operations Engineering and MES capabilities to internal customers and support regulatory interactions, inspections and audit responses.
• Business Impact & Continuous Transformation: Recommend and implement complex transformation and continuous improvement initiatives across site; measure and demonstrate business value, cost savings and quality improvements attributable to MES/Technical Operations Engineering change
• Coaching & Technical Mentorship: Guide, coach and mentor engineers, validation specialists and technical staff within the Technical Operations Engineering area; build capability around computerized system validation lifecycle and digital tool adoption.
• Cross-Functional Leadership: Lead cross-functional collaboration with Manufacturing, Quality Assurance, MS&T, Engineering/Automation, IT/Digital Manufacturing Systems, Training and Supply Chain to resolve complex operational and validation issues and deliver strategic projects.
• Communication & Technical Writing: Prepare high-quality technical documentation, validation artifacts, executive summaries and data-driven reports; communicate complex technical concepts clearly to senior leadership and non-technical stakeholders.
• Change Leadership & Adoption: Oversee introduction of new processes from identification of business need through implementation and formal acceptance by customers; support adoption through training, stakeholder engagement and effectiveness checks.
• SHE & Compliance Oversight: Drive and track compliance of own work and work of others with SHE and other applicable regulatory standards; escalate and remediate issues when required.

Essential Experience/Skills:

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical field
• 4+ years of experience in computerized system validation in a GMP-regulated environment
• Demonstrated ability to lead cross-functional validation efforts and inspections
• Hands-on experience with automation platforms, PCS, historian systems, MES and computerized system validation lifecycle documentation
• Experience developing tools and dashboards using Power BI, Power Apps, Power Automate, and Python

Desired Experience/Skills:

• Experience leading validation and lifecycle management of PCS or distributed control systems (DCS) used in GMP manufacturing environments
• Leading computerized systems validation (CSV) efforts
• Masters Degree
• Mentoring junior validation staff and contributing to validation strategy and continuous improvement initiatives
• Familiarity with GAMP 5, Annex 11, and 21 CFR Part 11 compliance requirements
• Proficiency with validation lifecycle tools such as HP ALM or ValGenesis
• Experience supporting audit readiness and responding to regulatory inspections
• Knowledge of lean validation or risk-based CSV approaches (e.g., CSA: Computer Software Assurance)