Gene Therapy Process Validation Engineer — Hybrid

BEPC Inc. - Business Excellence Professional Consulting; Carlsbad (CA); Hybrid; USD 119,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Job summary

BEPC Inc., a Business Excellence Professional Consulting firm, seeks a Process Validation Engineer for its client in Carlsbad, CA. This W2 contract role (12 months) features a hybrid work model with 3 days onsite and 2 days remote and focuses on viral vector manufacturing support.

The successful candidate will develop, review, and manage validation activities, acting as SME for process validation of unit operations.

Qualifications

• Education: Bachelor’s or Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or another Life Science-related field.
• Minimum of 7+ years of experience in a cGMP environment.
• 5+ years of experience with process validation, Process Performance Qualification (PPQ), and/or Continued Process Verification (CPV).

Responsibilities

• Develop and manage validation activities and execution plans.
• Provide technical leadership across cross-functional teams.
• Lead strategy for process validation of unit operations in viral vector manufacturing.
• Generate and approve validation protocols and reports.
• Coordinate risk assessments and process documentation within validated parameters.
• Ensure compliance with regulatory requirements and product licenses.
• Drive CPV strategies and continuous process verification initiatives.

Skills

BLA filing experience

Commercial manufacturing

Validation activities management

Education

Bachelor’s or Master’s in Biochemistry/ Chemistry/ Chemical Engineering/ Microbiology/ Life Science

Tools

AKTA Chromatography

XMO systems

UF/DF/TFF systems

Job description

BEPC Inc., a Business Excellence Professional Consulting firm, seeks a Process Validation Engineer for its client in Carlsbad, CA. This W2 contract role (12 months) features a hybrid work model with 3 days onsite and 2 days remote and focuses on viral vector manufacturing support.

The successful candidate will develop, review, and manage validation activities, acting as SME for process validation of unit operations.