Process Validation Engineer

About the role

Join a premier viral vector manufacturing facility in Carlsbad, CA, as a Lead Process Validation Engineer. In this dynamic CMO environment, you will drive process validation strategy, manage execution, and serve as the technical subject matter expert for cell and gene therapy manufacturing operations.

Location: Carlsbad, California
Job type: Contract
Salary: $57 - 72 per hour
Work hours: 9 to 5
Education: Bachelors

Responsibilities

• Define and implement robust Process Validation, Process Performance Qualification (PPQ), and Continued Process Verification (CPV) frameworks.
• Write complex risk assessments, manage validation impact assessments, and investigate process deviations to prevent repeat events.
• Lead studies on process hold times, homogeneity, and mixing, establishing drug substance manufacturing control strategies.
• Generate, review, and approve critical validation protocols, reports, and technical documentation.
• Serve as the Process Validation SME during customer meetings, regulatory audits, and cross-functional technical liaison efforts.

Qualifications

• Required: Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or related Life Sciences field.
• Required: 7+ years of experience in a cGMP manufacturing environment.
• Required: 5+ years of dedicated experience in Process Validation, PPQ, and CPV strategies.
• Preferred: 10+ years of process validation experience in a cGMP setting.
• Required: 5+ years of hands-on experience with cell culture upstream operations (bioreactors, clarification) or downstream purification (TFF, automated chromatography skids, sterile filtration).
• Required: Strong technical writing abilities and experience leading cross-functional teams without direct authority.

Skills

• Chemistry
• Microbiology
• Good Laboratory Practices (GLP)
• Good Manufacturing Practices (GMP)

Benefits

• Medical insurance
• Prescription coverage
• Dental insurance
• Vision insurance
• AD&D insurance
• Life insurance
• Short-term disability
• 401K plan

All benefits are based on eligibility.

Pay

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Schedule

Work hours: 9 to 5.