Senior Validation & Operational Excellence Engineer (CGMP)

Theragent Inc.; Arcadia (CA); On-site; USD 110,000 - 127,000; Full time

Job summary

Theragent Inc. in Arcadia, CA is seeking an Engineer III, Validation & Operational Excellence to drive validation, business analysis, and lean improvements for a CGMP cell and gene therapy facility. You will oversee validation lifecycle activities, collaborate with IT and operations, and help mature the validation program.

The role requires strong knowledge of CSV, GMP regulations, SDLC, and lean methods, with potential for temp-to-hire conversion in a fast-paced startup environment.

Qualifications

• 4-6+ years of validation, business analysis, and/or operational excellence experience in Pharma/Life Sciences CGMP
• Bachelor’s in life sciences or engineering; advanced degree is a plus
• Strong background in computer system validation (CSV) required
• Six Sigma certification is a plus

Responsibilities

• Lead GMP validation projects of moderate to high complexity with in-house/contracted resources
• Lead requirements gathering and qualification of IT systems for CGMP use (SDLC, data integrity, system integrations)
• Develop qualification/validation lifecycle docs and execute studies; review results
• Serve as Theragent Validation SME for project scopes and approaches
• Drive lean initiatives and define KPIs for continuous improvement

Skills

CSV validation

CGMP

SDLC

Data integrity

Lean methodologies

Interpersonal skills

Education

B.S. in Life Sciences or Engineering

Advanced degree (plus)

Tools

Microsoft Office Suite

Job description

Theragent Inc. in Arcadia, CA is seeking an Engineer III, Validation & Operational Excellence to drive validation, business analysis, and lean improvements for a CGMP cell and gene therapy facility. You will oversee validation lifecycle activities, collaborate with IT and operations, and help mature the validation program.

The role requires strong knowledge of CSV, GMP regulations, SDLC, and lean methods, with potential for temp-to-hire conversion in a fast-paced startup environment.