Manager, Equipment Program & Validation

Company: Velocity Bioworks Inc
Location: San Antonio
Posted on: February 14, 2026

Job Description:

Job Description Job Description Description: TITLE: Manager, Equipment Program & Validation REPORTS TO: Director, Engineering and Technical Services LOCATION: San Antonio, Texas (On-site) The Company Velocity Bioworks is a U.S.-based biopharma CDMO headquartered in San Antonio, Texas supporting funded programs as they move from development into manufacturing for clinical trials. We collaborate with sponsors who are past exploration and are ready to apply discipline, structure, and technical rigor to development, analytics, and manufacturing. Velocity is built to accelerate speed to clinic through aligned execution. Our work focuses on translating defined program goals into scalable manufacturing processes and robust analytical strategies. These activities are designed to support near-term clinical timelines while meeting quality requirements. We operate where quality and execution directly influence clinical and business progress. Position Summary Reporting to the Director, Engineering and Technical Support, the Manager, Equipment Program & Validation is responsible for Quality oversight and lifecycle management of equipment and computerized system validation programs supporting cGMP manufacturing, facilities, utilities, and laboratory systems at the Velocity Bioworks’ San Antonio site. This role is a senior quality and technical professional with broad knowledge of equipment lifecycle management, validation strategy, and data integrity principles across manufacturing and laboratory environments. The Manager, Equipment Program & Validation serves as a subject matter expert (SME) for equipment and computerized system validation, ensuring validation activities are compliant with Velocity Bioworks’ internal standards, regulatory requirements, and industry best practices. The position requires strong cross-functional collaboration with Engineering, Validation, IT, Quality Operations, QC, R&D Quality, and Vendor Management. The ideal candidate demonstrates sound judgment, ownership, and leadership capability, and thrives in a fast paced, multiclient CDMO environment while maintaining a strong quality mindset. Key Responsibilities Provide QA oversight of the full equipment and computerized system lifecycle, including user requirements, risk assessments, validation strategy, IQ/OQ/PQ, periodic review, change management, and decommissioning. Partner with Engineering, Validation, IT, Quality Operations, R&D Quality, and QC to manage validation project deliverables, timelines, and compliance expectations. Serve as the Quality SME for equipment and computerized system validation activities, including CSV, data integrity, and system use in GxP environments. Review and approve validation protocols, reports, and associated quality documentation. Author, review, and approve SOPs, policies, and work instructions related to equipment qualification, validation, CSV, and data integrity. Support and actively participate in Quality Systems, including Change Control, Deviations, Investigations, CAPA, and Document Management. Coordinate with IT and Engineering to maintain an accurate and current inventory of GxP equipment and computerized systems. Provide expertise in issue resolution, root cause analysis, and continuous improvement related to equipment, software validation, and data integrity risks. Support vendor qualification and oversight activities for validation related suppliers, service providers, and system vendors. Prepare for and support regulatory inspections, client audits, and internal audits as the QA SME for equipment and system validation. Identify, assess, escalate, track quality risks and compliance gaps, and communicate status to Quality and site leadership. Develop and deliver training for system users and stakeholders on validated equipment and computerized systems. Contribute to defining and executing Velocity Bioworks’ operational and quality strategies. Maintain regular onsite presence; attendance at the San Antonio site is considered an essential function. Work 40 hours per week with flexibility to support business needs, which may include additional hours, weekends, or holidays as required. Requirements: Education & Experience Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related discipline, with a minimum of 6 years of relevant industry experience. Master’s degree in a scientific or engineering discipline preferred. Comprehensive knowledge of GxP regulations, including applicable sections of the Code of Federal Regulations. Demonstrated expertise in equipment validation, CSV, data integrity, and regulatory expectations, including 21 CFR Part 11 and Annex 11. Strong understanding of performance qualification activities for manufacturing and laboratory equipment. Experience applying risk-based approaches consistent with ICH Q8, Q9, and Q10. Proficiency with Microsoft Office applications (Word, Excel, PowerPoint). Knowledge & Skills Strong verbal and written communication skills with the ability to interact effectively at all organizational levels and with external partners. Ability to work independently with minimal supervision while managing multiple priorities and challenging timelines. Demonstrated ability to collaborate cross functionally in a matrixed, multiclient environment. Detail oriented, organized, and capable of completing work in a timely, accurate, and thorough manner. Customer focused mindset with a commitment to quality, compliance, and continuous improvement. Ability to read, interpret, and analyze complex technical and regulatory documents and develop practical, compliant solutions. Professional demeanor with the ability to respond effectively to sensitive inquiries, audit observations, and customer questions. Physical Requirements & Working Environment Flexibility in working hours is required; occasional weekend work or adjusted schedules may be necessary. The role is primarily performed in an environmentally controlled manufacturing, laboratory, and office environment with moderate noise levels. Regularly required to sit, stand, walk, reach, and communicate verbally. May occasionally be required to lift or move materials weighing up to 20 pounds. Must have sufficient vision, manual dexterity, and coordination to use computers, review documentation, and interact with automated equipment.

Keywords: Velocity Bioworks Inc, New Braunfels , Manager, Equipment Program & Validation, Engineering , San Antonio, Texas