Sr. Validation Engineer

About the Role We are seeking a highly motivated Sr. Validation Engineer to serve as the subject matter expert for laboratory instrumentation, qualification, compliance, and lifecycle management within a GMP-regulated analytical laboratory. This individual will play a critical role in ensuring laboratory equipment remains compliant, audit-ready, and fully operational while leading instrument qualification, software validation, preventive maintenance, and laboratory infrastructure initiatives. This is an excellent opportunity for an experienced analytical scientist who enjoys combining technical expertise, compliance leadership, and cross-functional collaboration to support a growing organization! Qualifications Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline. 4+ years of experience in GMP-regulated analytical laboratory environments. Hands-on experience qualifying analytical instrumentation and software platforms, including IQ/OQ/PQ execution. Strong experience with: HPLC, LC-MS, GC-MS/FID, FTIR, GPC-MALS or comparable analytical technologies In-depth knowledge of FDA regulations, GMP requirements, data integrity principles, and 21 CFR Part 11. Experience authoring validation protocols, qualification reports, URS documents, and technical documentation. Key Responsibilities Instrumentation & Lifecycle Management Serve as the primary owner and technical expert for laboratory instrumentation, ensuring all systems remain qualified, compliant, and operational. Manage the complete lifecycle of analytical instruments, including acquisition, qualification, calibration, maintenance, change control, vendor management, and decommissioning. Lead instrument onboarding and implementation activities for new laboratory equipment and software systems. Coordinate equipment repairs and troubleshooting efforts to minimize downtime and ensure operational continuity. Qualification, Validation & Compliance Plan, coordinate, and execute IQ/OQ/PQ activities for analytical instruments and associated software platforms. Author and maintain qualification and validation documentation, including: User Requirement Specifications (URS) Validation Protocols Qualification Reports Technical Documentation Support computerized system validation (CSV) initiatives and ensure compliance with FDA regulations and 21 CFR Part 11 requirements. Maintain compliance with data integrity standards governing electronic records and electronic signatures. Audit Readiness & Quality Systems Ensure laboratories remain inspection‑ready by maintaining accurate, complete, and current instrument and validation records. Drive continuous improvement initiatives focused on compliance, operational efficiency, and audit readiness. Serve as a subject matter expert on GMP regulations, FDA guidance, data integrity requirements, and laboratory documentation practices. Cross‑Functional Leadership Partner closely with Quality Assurance, IT, EHS, and R&D teams on compliance, validation, and operational initiatives. Lead and support laboratory expansions, instrument relocations, facility upgrades, and infrastructure projects. Provide project updates and technical guidance to stakeholders across multiple functions. Own high‑impact initiatives that strengthen laboratory capabilities and support organizational growth. Job Type & Location This is a Contract position based out of San Diego, CA. Pay and Benefits The pay range for this position is $72.00 - $76.00/hr. Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long‑term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in San Diego, CA. Application Deadline This position is anticipated to close on Jul 30, 2026. Equal Opportunity & EEO Statements The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr