Validation Lead

Job Title: Biologics Instruments Qualification & Validation Lead Location: Foster City, CA (Onsite) Long Term Rolling Contract Description:- The Biologics Instruments Qualification & Validation Lead is responsible for ensuring that all analytical, bioanalytical, and process-support instruments used in biologics development and QC/QA laboratories operate in a validated, compliant, and audit-ready state. This role oversees the full lifecycle of equipment qualification (URS -> DQ -> IQ/OQ/PQ), manages risk-based validation strategies, ensures data integrity (ALCOA+), and leads cross-functional teams through regulatory-aligned validation activities. Key Responsibilities Lead the planning, execution, and approval of instrument qualification (IQ/OQ/PQ) for biologics R&D, QC, and manufacturing support labs. Develop and maintain risk-based validation strategies aligned with GAMP 5, ICH Q9, and internal QMS. Ensure qualification packages meet FDA, EMA, MHRA, and global regulatory expectations . Oversee validation of complex biologics instrumentation , including: HPLC/UPLC systems CE-SDS and icIEF platforms Flow cytometers qPCR/dPCR systems Plate readers, spectrophotometers Bioreactor control systems Chromatography skids Biosafety cabinets, incubators, cryogenic freezers 2. Validation Documentation & Compliance Author, review, and approve URS, DQ, IQ/OQ/PQ protocols , traceability matrices, and validation summary reports. Ensure documentation is audit-ready , traceable, and compliant with Part 11, Annex 11, and ALCOA+. Maintain equipment lifecycle documentation including periodic reviews , requalification, and retirement. 3. Data Integrity & Technical Controls Implement and validate audit trails , access controls , electronic signatures , and backup/restore capabilities. Ensure validated state of instrument software , firmware, and connected systems. Partner with IT/Automation to validate networked instruments , integrations, and secure data flows. 4. Cross-Functional Collaboration Work closely with QC, QA, Manufacturing, MS&T, R&D, IT, Facilities, and Vendors . Lead technical discussions with vendors to ensure qualification packages meet regulatory expectations. Provide SME guidance during change control , deviations , and CAPA investigations . 5. Inspection Readiness & Regulatory Support Prepare and support regulatory inspections (FDA, EMA, MHRA, PMDA). Lead mock audits and ensure validation packages withstand regulatory scrutiny. Respond to auditor questions with clear, defensible, science- and risk-based rationale. Drive improvements in validation processes using CSA principles , automation, and standardized templates. Implement best practices for instrument lifecycle management and data governance . Mentor junior validation engineers and elevate documentation quality across teams. Required Qualifications Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, or related field . 7-12+ years of experience in equipment qualification, validation, or instrumentation engineering in a GxP biologics environment. Deep knowledge of GAMP 5 , ICH Q7/Q9/Q10 , 21 CFR Part 11 , EU Annex 11 , and global regulatory expectations. Hands‑on experience qualifying biologics‑specific instruments (HPLC, CE-SDS, flow cytometry, qPCR, bioreactors). Strong understanding of data integrity , computerized system validation, and laboratory workflows. Proven ability to lead cross‑functional teams and manage multiple validation projects. Preferred Qualifications Experience with biologics QC release testing , potency assays, or analytical method validation. Experience validating cloud-based or networked instrument software . Familiarity with LIMS, CDS, ELN, and MES integrations. Prior experience supporting regulatory inspections . Strong technical writing skills and ability to produce executive‑and audit‑ready documentation . Core Competencies Technical mastery of biologics instrumentation Regulatory interpretation and compliance mindset Strong communication and documentation skills Problem‑solving and deviation management Ability to influence QA and stakeholders with data‑driven rationale #J-18808-Ljbffr Fusion Life Sciences Technologies LLC