Velocity Bioworks · 2 days ago
Manager, Equipment Program & Validation
San Antonio, Texas Metropolitan Area
Full-time
Onsite
Senior Level
6+ years expVelocity 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. The Manager, Equipment Program & Validation is responsible for Quality oversight and lifecycle management of equipment and computerized system validation programs supporting cGMP manufacturing and laboratory systems. This role requires strong cross-functional collaboration and serves as a subject matter expert for equipment validation activities.
Pharmaceuticals
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
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related discipline, with a minimum of 6 years of relevant industry experience
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)
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
Preferred
Master's degree in a scientific or engineering discipline preferred
Company
Velocity Bioworks
Velocity Bioworks is a contract development and manufacturing organization (CDMO) based in San Antonio, Texas.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase