Overview
Hybrid
Depends on Experience
Contract - W2
Contract - Independent
Skills
Gene Therapy and CAR-T therapy workflows.
Job Details
Greeting from Lightning Minds
This is Rakesh with Lightning Minds. We Lightning Minds is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients.
Job Description : Business Analyst
Location : Santa Monica, CA (Onsite)
Type : Contract
Position Summary
We are seeking an experienced Business Analyst with a strong background in Validation Documentation across Clinical Trial and Manufacturing environments. The ideal candidate will bring proven expertise in IT Systems Validation, as well as hands-on experience with Cell and Gene Therapy and CAR-T Therapy operations.
Key Responsibilities
* Collaborate with cross-functional teams to gather and document business and technical requirements for validated systems.
* Prepare, review, and manage validation documentation (e.g., URS, FRS, IQ, OQ, PQ, traceability matrices).
* Ensure compliance with GxP, FDA 21 CFR Part 11, and industry validation standards.
* Support validation lifecycle activities for clinical trial systems and manufacturing IT systems.
* Liaise with QA, IT, and process engineering teams to ensure readiness for audits and inspections.
* Facilitate communication between business users and technical teams to ensure requirements are understood and implemented correctly.
Required Skills & Experience
* 5 8+ years of experience as a Business Analyst in Life Sciences / Biopharma.
* Strong understanding of Validation documentation and IT Systems Validation processes.
* Experience supporting systems in Clinical Trials, Manufacturing, and Quality domains.
* Familiarity with Cell & Gene Therapy and CAR-T therapy workflows.
* Solid knowledge of CSV (Computer System Validation) methodologies.
* Excellent communication, documentation, and stakeholder management skills.
Nice-to-Have
* Experience with systems like LIMS, MES, QMS, eTMF, or CTM.
* Prior work in regulated biotech / pharmaceutical environments.
* Knowledge of GAMP 5 and Annex 11 guidelines.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.