Senior Biologics Instrumentation 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

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