Biologics Instruments Qualification & Validation Lead

United Pharma Technologies Inc; Foster City (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

United Pharma Technologies Inc in Foster City, CA seeks a Biologics Instruments Qualification & Validation Lead to ensure instruments used in biologics development and QC labs are qualified, validated, and audit-ready. You will manage IQ/OQ/PQ programs and lead cross-functional teams through regulatory-aligned validation activities.

You will develop risk-based validation strategies, maintain ALCOA+ data integrity, and collaborate with QA, QC, IT, and facilities to support inspections and

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).

Responsibilities

• Lead IQ/OQ/PQ qualification planning, execution, and approval for R&D, QC, and manufacturing labs.
• Develop 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, CE-SDS, flow cytometry, qPCR, bioreactors.
• Collaborate cross-functionally with QC, QA, IT, and Vendors; provide SME guidance during change control, deviations, and CAPA investigations.

Skills

HPLC/UPLC systems

CE-SDS and icIEF platforms

Flow cytometry

qPCR/dPCR systems

Biologics instrumentation validation

Education

Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, or related field

Tools

Regulatory/compliance tools

Job description

Position:

Biologics Instruments Qualification & Validation Lead

Location

Foster City, CA (Onsite)

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

• 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.