Sr Process Validation Engineer

The Senior Process Validation Engineer will be responsible defining, implementing, and maintaining a robust process validation program. This will consist of revising current practices, and ensuring that best practices are implemented. The process validation program includes, but is not limited to, biological growth processes, aseptic processing, cleaning, and sterilization processes. The Sr. Engineer will also serves as a source of information for others in the company, including a training resource for Associate/Validation Engineers, contractors, and vendors.

The successful Sr. Process Validation Engineer will work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. They will exercise judgment and manage projects with little direction from above, within broadly defined practices and policies. They must be able to select methods, techniques, and evaluation criteria in order to obtain desired validation results. He/she will determine which methods and procedures will be best utilized for validation testing, and will guide and direct others in the development of validation documentation.

Other duties:
Develop Policy & Procedures and Manage Validation Programs

Act as Process Validation subject matter expert for resolution of deviations, assessment of change orders and other quality system actions

Oversee/execute selected studies and protocols for processes and systems.

Write selected studies, plans, protocols, and reports for processes and systems

Perform periodic process review and re-validation to ensure continued compliance

Keep abreast of current technology by attending professional meetings and seminars and reading technical literature.

Mentor and train junior employees on Process Validation

Required Skills/ Knowledge:
* Management of complex validation projects
* In depth, working knowledge of 2004 FDA Aseptic Process Guidance for Industry
* Solid background and experience with GMP's
* In depth working knowledge of 2011 FDA Process Validation Guidance for Industry
* Experience implementing Process Validation Program
* Quality Risk Management concepts

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