What are the responsibilities and job description for the Validation Engineer position at Katalyst HealthCares & Life Sciences?
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.
- 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.
