Jobs in Fort Collins Larimer County, 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.

Company

Henderson Management has been in business since 1994 and is locally owned and operated. Henderson is the largest property management company in Northern Colorado, recognized for our passion, core values, and experience as the authority in property management. As a Character First company, we are committed to always following our character values and doing the right thing. We have a team that works together with built systems and processes in place to help everyone understand their roles and responsibilities. We provide ongoing training with our weekly departmental and company meetings. Light hearted and competitive team that works hard and plays hard with many company team building events throughout the year.

The Role

Henderson Management & Real Estate is currently seeking candidates for Full Time Property Manager Assistant to join our growing company. If you are a high-energy individual who wants opportunities to learn and grow, if you are motivated, like being challenged on a regular basis, organized, and have a proven track record for success, we would like to talk with you! You will be supported by a team of professionals in other specialized areas that help make your daily duties as a Property Manager easier. This role does require a mix of both office and field work.

Responsibilities include but are not limited to:

• Ensure owners/investors are satisfied and understand the value in our relationship so that they become customers for life
• Proactively communicate with owners and other members of the Henderson team on all issues as needed to support the Property Manager
• Perform property walks to evaluate properties for maintenance needs and property updates
• Working through maintenance issues and projects on properties
• Reviewing monthly Owner's Statements looking for accuracy and budget issues
• Make sure owners are proficient at understanding their owners statements and are receiving the reports they need
• Handling all property emergencies in a timely manner to prevent property damage
• Tracking ROI

Qualifications and Skills

• Must be able to pass a background check and have a clean driving record
• Fast learner, incredibly organized and proficient in time management
• Customer service and detail oriented
• Able to work independently showing initiative while still following company processes
• Must have at least a year of experience in the Property Management industry
• Fast learner, incredibly organized, and detail oriented
• Strong, effective, written and verbal communication skills
• Knowledge of Fair Housing laws
• Proficient in the use of Microsoft Office and Google Docs
• Prior property management experience is a plus.
• Experience working with Appfolio is preferred

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Independent Contractor

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• Consistent access to a smartphone

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