Senior Analytical Scientist (Instrumentation)

Analytical Scientist Location: San Diego, CA (Onsite) About the Role We are seeking a highly motivated Analytical Scientist 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. 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, and 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. Required Qualifications Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline. 5+ 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. Demonstrated expertise in instrument qualification and validation, computerized system validation (CSV), instrument troubleshooting and maintenance, preventive maintenance and calibration programs, vendor and change control management, 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. Strong project management and organizational skills with the ability to manage multiple priorities simultaneously. Excellent communication and collaboration skills. Preferred Qualifications Master's degree in a scientific discipline. Experience supporting laboratory expansions, equipment relocations, or facility build‑outs. Experience collaborating with QA, IT, EHS, and R&D teams in a regulated environment. Proven ability to lead compliance-focused initiatives and drive continuous improvement efforts. Passion for advanced analytical technologies and laboratory excellence. Why Join Us? Opportunity to take ownership of critical laboratory instrumentation and compliance programs. Exposure to advanced analytical technologies in a growing GMP-regulated environment. Highly visible role with significant impact on audit readiness, laboratory expansion, and operational excellence. Collaborative culture that values technical expertise, innovation, and continuous improvement. Opportunity to work cross-functionally with scientific, quality, engineering, and regulatory teams. Work Environment This position is 100% onsite in San Diego, CA and operates within a fast-paced GMP-regulated laboratory environment focused on quality, compliance, and scientific excellence. Standard work hours are approximately 8:30 AM–5:00 PM, with occasional flexibility required to support audits, validation activities, and critical laboratory projects. The successful candidate will collaborate with a multidisciplinary team across Quality Assurance, IT, EHS, and R&D while playing a key role in the laboratory's continued growth and expansion. 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 29, 2026. Equal Opportunity Statement 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. Accommodation Notice 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 View email address on click.appcast.io 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 Actalent