Validation Engineer

Responsibilities:

Coordinate sample builds and maintain traceability documentation.

Prepare process validation protocols (IQ/OQ/PQ) and generate accompanying test plans/reports.

Route and track all protocol documents for proper approvals.

Characterize new process equipment.

Document experiments and results in engineering reports.

Create and present summary presentations to management.

Collaborate and coordinate with outside vendors.

Provide technical support to engineering and provide line support as required.

Obtain test data and provide statistical analysis to generate status reports for engineering.

Initiate revision of controlled drawings of components and assemblies as needed.

Create or revise assembly procedure documents.

Provide process expertise and training as necessary.

Identify safety issues in the immediate work environment and other work areas and recommend solutions for improvement. Requirements:

BS in Biomedical/Mechanical/Chemical Engineering.

Experience in working in a clean room environment or wet lab environment.

Experience in analyzing large data sets and performing relevant statistical analysis.

Proficient in writing technical reports, procedures, and/or reference documents.

Ability to multitask and meet deadlines.

Must have excellent verbal and written communication skills.

Must have experience in developing Design of Experiments (DOEs).

Must have strong attention to detail.

Proficient in Minitab statistical analysis software.

Minimum BS in Biomedical/Mechanical/Chemical Engineering.

Medical device or healthcare industry experience.

Proficient in Minitab statistical analysis software.