Manager, Equipment Program & Validation
Listed on 2026-02-16
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Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering, Biomedical Engineer
TITLE: Manager, Equipment Program & Validation
REPORTS TO: Director, Engineering and Technical Services
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 SummaryReporting 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.
- Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Chemistry, or…
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