Sr. Quality Automation and AI CSV Engineer - Windsor, CO

Sr. Quality Automation and AI CSV Engineer

The Senior Automation and AI CSV Engineer will lead the design, implementation, and validation of automated systems and AI-driven solutions within a sterile injectable pharmaceutical manufacturing environment. This role ensures compliance with regulatory requirements (FDA, EMA, ICH) and company standards for computerized systems, automation platforms, and AI-enabled technologies used in production, quality control, and data analytics.

Essential Duties & Responsibilities

• Automation & AI Validation:
• Develop and execute validation strategies for automated systems, robotics, and AI-based tools in compliance with GAMP 5, 21 CFR Part 11, FDA’s CSA for Production and Quality System Software, Annex 11, Annex 22, and PIC/S.
• Perform risk assessments and ensure data integrity for AI-driven decision-making systems.
• Author and review validation documentation (URS, FS, DS, IQ/OQ/PQ protocols, reports).
• System Lifecycle Management:
• Oversee system implementation, upgrades, and change control for automation and AI platforms.
• Collaborate with IT, Engineering, and Quality teams to maintain validated state of systems.
• Regulatory Compliance:
• Ensure adherence to cGMP, FDA, EMA, and global regulatory guidelines for sterile injectable manufacturing.
• Support audits and inspections by providing validation evidence and technical expertise.
• Innovation & Continuous Improvement:
• Identify opportunities to integrate AI and advanced analytics for process optimization and predictive maintenance.
• Drive digital transformation initiatives.
• Quality Oversight & Approval:
• Provide independent quality oversight for automation and AI validation activities.
• Review and approve validation protocols, reports, and change control documentation to ensure compliance and data integrity.
• Act as a quality representative during system implementation and qualification phases.
• Adhere to company and departmental timelines with high accuracy and quality.
• Maintain an atmosphere of teamwork, cordiality, and respect towards co-workers.
• Performs other duties as assigned.

Core Values

This position is expected to operate within the framework of our Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Knowledge, Skills & Abilities

• Excellent organizational and project management skills.
• Excellent oral and written communication skills.
• Ability to work independently with minimal supervision and as part of a cross-functional team.
• Advanced knowledge of Automation and CSV/CSA principles, industry guidance, regulatory requirements, cGMP practices, and ICH guidelines.
• Strong project management and cross-functional leadership skills.
• Ability to author strong technical reports free of errors.
• Advanced knowledge with Microsoft Office Suite, and various GMPS systems such as Veeva eQMS, Maximo CMMS, BMS, LIMS, CDS, and ERPs.
• Familiarity with SCADA, PLC, MES, and AI platforms from simple context analysis tools to large language modeling, prompt engineering and the role of human interaction for process engineering and establishment of trustworthy data.
• Advanced troubleshooting and problem-solving skills.
• Ability to manage multiple projects concurrently and under tight time constraints.

Education & Experience

• Bachelor’s degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field required
• Master’s degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field preferred
• Minimum of 8 years’ experience in pharmaceutical automation and computerized system validation.
• Strong knowledge of sterile injectable manufacturing processes and aseptic techniques.
• Hands-on experience with AI/ML applications in manufacturing or quality systems preferred.
• Expertise in GAMP 5, 21 CFR Part 11, Annex 11 and knowledge of Annex 22 compliance.
• Proficiency in risk-based validation and data integrity principles.

Working Conditions

• Working conditions include general office environment.
• Business demands may require working extended hours.