Senior Validation Engineer | Durham, North Carolina
Position Overview
The Sr. Validation Engineer would be responsible for ensuring that processes and systems such as those associated with facilities, equipment, system, cleaning methods, and analytical instrumentation are fully qualified and performing as designed.
Primary Responsibilities
- Responsible for creation, recommending, and executing validation strategies to provide documented evidence that facilities, equipment, system, cleaning methods, and analytical instrumentation have been commissioned, qualified and/ or validated in a manner that meets or exceeds regulatory and cGMP requirements for GMP manufacturing operations
- Lead the validation program by writing, executing or providing oversight for protocols and reports documenting the validation of facilities, equipment, system, cleaning methods, and analytical instrumentation
- Provide oversight and lead projects requiring validation, which includes, but not limited to, new equipment, systems, cleaning processes, and analytical instrumentation, change control, periodic review, and deviation management
- Provide direction and support for contract validation resources
- Provide direction and collaborate with external resources for equipment, systems, cleaning processes, analytical instrumentation, change control, periodic review, and deviation management
- Develop, create, update and edit SOP’s for validation processes, as needed
- Ensures Humacyte or other required trainings/certifications are up-to-date
- Other duties, as assigned
Specific Skill Requirements
- Ability to handle multiple projects and deliver on aggressive project timelines with little supervision
- Ability to establish, manage, and present, in a professional manner validation project requirements and status
- Ability to communicate clearly to all levels within the organization
- Understanding of statistical evaluation tools
- The position requires independent performance, time management, manage multiple validation projects simultaneously, and analyze and resolve the unique compliance needs presented by the company’s Bioprocessing Works as a team player, and serves as a model by participating in activities that involve cooperating with others
General Skill Requirements
- 8+ years of experience as a validation professional
- At least five years of experience in the pharmaceutical industry, preferred
- Experience leading and directing validation resources (contractors, vendors, etc.)
- Knowledge of cGMP requirements in the US and EU, required
- Knowledge of current industry expectations of validation requirements for process validation, cleaning validation, computer validation, and equipment qualification, required
- Will spend a portion of time in clean room environment to perform validation activities and will be required to meet applicable gowning and personal protective equipment guidelines