Job Title: Senior Process Validation Engineer

Location: San Diego, CA (Onsite)

Duration: 12+ Months

Overview:

Seeking a Senior Process Validation Engineer to lead process validation activities and ensure compliance within a GMP-regulated manufacturing environment.

Required Experience:

• Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical preferred)
• 5+ years of hands-on validation experience
• Strong experience in process validation (IQ/OQ/PQ)
• Experience in FDA-regulated industry (Medical Device / Pharma)
• Strong knowledge of GMP and validation lifecycle
• Experience with risk assessments and process characterization
• Ability to work independently and manage multiple validation projects

Key Responsibilities:

• Lead process validation activities (IQ/OQ/PQ)
• Develop and execute validation protocols and reports
• Perform process characterization and risk assessments
• Collaborate with cross-functional teams (Quality, Manufacturing, R&D)
• Ensure compliance with GMP and regulatory requirements
• Support validation timelines and deliverables
• Drive continuous improvement in validation processes