Biologics Instruments Qualification Lead

Job Description:

Title: Biologics Instruments Qualification & Validation Lead
Location: Foster City, CA (Onsite)
Duration: Long Term Rolling Contract

Job Description:

Position Summary:

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:

1. Equipment Qualification & Validation Leadership

• 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.

6. Continuous Improvement

• 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
• Risk‐based decision‐making
• Regulatory interpretation and compliance mindset
• Cross‐functional leadership
• Strong communication and documentation skills
• Problem‐solving and deviation management
• Ability to influence QA and stakeholders with data‐driven rationale