United Pharma · 1 day ago
Validation Engineer -CQV Lead
California, MD
Full-time
Onsite
Senior Level, Lead/Staff
15+ years expUnited Pharma is seeking a senior-level CQV Lead with extensive hands-on experience supporting gene therapy manufacturing equipment to lead qualification and validation activities for a high-priority LP2 manufacturing program. This role will be responsible for end-to-end CQV delivery, ensuring full cGMP compliance and inspection readiness while providing strategic direction and hands-on execution across various processing systems.
Staffing & Recruiting
Hiring Manager
Chandra Sekhar.s
Responsibilities
Lead the development, execution, and approval of IQ/OQ/PQ protocols for gene therapy manufacturing equipment
Perform qualification of upstream, downstream, and fill-finish systems, including:
Single-use bioreactors
TFF systems
Chromatography skids
Isolators and aseptic processing equipment
Author and manage URS, RTM, FAT/SAT protocols, and final validation summary reports using a risk-based approach
Execute protocols on the floor, providing hands-on troubleshooting, deviation resolution, and CAPA support
Ensure all CQV activities comply with cGMP standards and are maintained in an audit-ready state
Serve as the primary CQV interface with equipment vendors, engineering, QA, and manufacturing teams
Provide technical mentorship and oversight to junior CQV engineers
Support regulatory inspections and internal audits, as required
Qualification
Required
15+ years of Commissioning, Qualification, and Validation (CQV) experience
Direct, hands-on experience qualifying gene therapy equipment is required
Demonstrated expertise in authoring validation documentation from scratch and executing protocols in a GMP environment
Strong background in facility, utility, and equipment qualification
In-depth knowledge of: Single-use technologies, Aseptic processing, GMP utilities, Computerized system validation (CSV)
Excellent technical writing, documentation, and communication skills
Bachelor's degree in Engineering or Life Sciences
Company
United Pharma
United Pharma Solutions is a professional company dedicated to business development in the pharmaceutical industry.
11-50 employees
H1B Sponsorship
United Pharma 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 (50)
2024 (81)
2023 (77)
2022 (69)
2021 (46)
2020 (57)
Funding
Current Stage
Early StageCompany data provided by crunchbase