Validation Engineer

We are looking for Validation Engineer for our client in Draper, UT

Job Title: Validation Engineer

Job Location: Draper, UT

Job Type: Contract

Job Overview:

Requirement/Must Have:

• Bachelor's Degree in Engineering or Scientific field with 2+ years related work experience.
• Master's Degree or equivalent and internship, senior projects or thesis in Engineering or Scientific field with industry or industry/education experience.

Responsibilities:

• Review and approve equipment validations (IQ, TFIQ) and asset management actions.
• Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP and LEAN methods) for design for manufacturing and for continuous process improvement.
• Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes and reduce risk.
• Collaborate with engineering teams to ensure successful transfers.
• Develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team where applicable for the plant site.
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• Provide support to process validation and production builds.
• Support/lead TMV.
• Develop PMV and Process Validation plans.

Nice to Have:

• CQE (Certified Quality Engineer), if applicable.

Skills:

• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Solid problem-solving, organizational, analytical and critical thinking skills.
• Solid understanding of processes and equipment used in assigned work.
• Ability to contribute to process improvements.
• Ability to work independently and manage activities to accomplish objectives.
• Ability to build productive internal/external working relationships.
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
• Basic understanding of statistical techniques.
• Previous experience working with lab/industrial equipment.
• Knowledge of and adherence to Quality systems.