Engineer III, Validation

Become part of our team as a Validation Engineer III, where you will lead validation activities for clinical and commercial drug substance manufacturing. Oversee quality documentation, ensure regulatory compliance, and provide technical direction. Ideal for experienced professionals with expertise in validation engineering and cGMP environments.

Skills

• validation
• cgmp
• fda/industry regulations
• sop drafting
• detail cgmps
• regulatory compliance
• deviation investigation
• change control
• process qualification
• data integrity
• 21cfr part 11
• risk assessment
• gap analysis
• cqv
• validation master plans
• requalification program
• production reporting
• audit reporting
• process improvement
• single use technology
• process design
• facility qualification
• utility qualification
• project management
• cross-functional collaboration
• technical leadership