Tolmar · 1 month ago
Sr Quality Automation and AI CSV Engineer (Onsite)
Windsor, CO
Full-time
Onsite
Senior Level, Lead/Staff
$125K/yr - $135K/yr
8+ years expTolmar Inc. is a company focused on pharmaceutical manufacturing, and they are seeking a Senior Automation and AI CSV Engineer to lead the design, implementation, and validation of automated systems and AI-driven solutions. This role ensures compliance with regulatory requirements and company standards while overseeing the quality and validation of these systems.
BiotechnologyHealth CareManufacturing
Responsibilities
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)
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
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
Identify opportunities to integrate AI and advanced analytics for process optimization and predictive maintenance
Drive digital transformation initiatives
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
Qualification
Required
Bachelor's degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field required
Minimum of 8 years' experience in pharmaceutical automation and computerized system validation
Strong knowledge of sterile injectable manufacturing processes and aseptic techniques
Advanced knowledge of Automation and CSV/CSA principles, industry guidance, regulatory requirements, cGMP practices, and ICH guidelines
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
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
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
Preferred
Master's degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field
Hands-on experience with AI/ML applications in manufacturing or quality systems
Benefits
Bonus Eligible
Benefits information: https://www.tolmar.com/careers/employee-benefits
Company
Tolmar
TOLMAR is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company.
1001-5000 employees
H1B Sponsorship
Tolmar has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (5)
2022 (3)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
A
Anil D'souza
Chief Executive Officer
Gerald Wallner
Data Integrity Manager
Recent News
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