Validation Engineer 2 - Product R&D

- Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or other Engineering or Scientific field with 4+ years of experience in process or product development/validation

- Master's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or other Engineering or Scientific field with 3+ years of experience in process or product development/validation

- 2+ years of experience with FMEA/risk analysis, product failure and root cause analysis - 3+ years of experience with process and product/equipment validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)

- Experience in Medical Device or Life Science industries - Experience with filtration and chromatography products

- Experience with Product Development Process (PDP) and working on cross functional teams - Experience in statistical analysis tools such as Capability, Gage R&R, DOE using Minitab - Capable in the development and execution of test method validations - Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements for products used in biopharmaceutical/med device industry - Experience in equipment troubleshooting and repairs