Validation Engineer II - Contract

Position: Engineer II,Req#: 18067-1Location: Draper, UT (100% Onsite)Duration: 9+ Months Contract with high possibility of extension

Job Description:

Education and Experience:

• Bachelor's Degree Engineering or Scientific field with 2 years related work experience Required or
• Master's Degree or equivalent and internship, senior projects or thesis in Engineering or Scientific field with including either industry or industry/education Required
• Other: CQE (Certified Quality Engineer), if applicable Preferred
• Equipment Validation experience is required.

Technical 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
• Developing solutions to a variety of problems of moderate scope and complexity
• Ability to contribute to process improvements
• Work is performed independently and reviewed upon completion for soundness in technical judgment, overall adequacy and accuracy
• Participates in determining objectives of assignment; arranges own activities in accomplishing objectives
• Contributes to the completion of more complex organizational projects and goals
• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• 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 required
• 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
• Knowledge of and adherence to Quality systems

Job Responsibilities:

• Provides support to the following activities (40%):

• Process validation and production builds
• Support/lead TMV
• PMV, Process Validation plans

• Review and approve equipment validations (IQ, TFIQ) and asset management actions. 15%
• Optimize to 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 15%
• Collaborate with engineering teams to ensure successful transfers 10%
• May 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. 10%
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes 10%

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