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Site Validation Engineer

Trillium Professional is now seeking a Site Validation Engineer in Holdrege, NE!

The Site Validation Engineer is responsible for execution and implementation of validation initiatives in support of product design activities and maintenance of the site validation process. Additional responsibilities include cross functional support for the Quality Engineering and Quality Systems group as well as active participation in preparation and conduction of FDA, ISO, or other 3rd party audits. This position is also responsible for validation and GMP/Compliance Training within the plant in conjunction with the Quality Systems and Quality Engineering Leaders. This position is responsible to build sound technical and organizational competence within area of responsibility. Ensure the systems comply with applicable government regulations and standards. Comply with all quality policies, procedures, and practices through consistent application of sound quality engineering/assurance principles.

Essential functions include but are not limited to:
-Support the plant on assigned new and existing product initiatives with technical expertise and determine associated resource needs to accomplish project goals.
-Develop and maintain the Validation Master Plan and validation tracking schedule.
-Provide visibility related to all validation activities through tracking and reporting plant metrics.
-Support and influence change management within the plant: liaison between the core team, program managers, and Global quality.
-Conduct training relevant to validation process and procedures.
-Approve protocols and reports for all validation and change control activities to ensure compliance to established procedures.
-Participate in Global validation team meetings as required.
-Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.
-Provide leadership and function as a respondent during FDA, ISO, -Corporate or other 3rd party audits.
-Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles.
-Build interactive working and strategic relationships between company Holdrege manufacturing, business and corporate quality management and other staff.
-Perform other duties as assigned by the Team Leader and required to support the needs of the business.

Annual salary is $85k/year. Apply now!

Basic Requirements:
-B.S. degree in Engineering (Industrial, Mechanic) or similar
-3+ Years of Quality experience including Validation and Quality Engineering responsibilities.
-Statistical and problem-solving skills
-Strong understanding of failure analysis
-Experience with Statistical software
-Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices.

Preferred Requirements:
-Demonstrate success with statistical and problem-solving methodologies.
-Strong understanding of failure analysis, test methods and engineering tolerances.
-Strong verbal, written and interpersonal skills.
-Proficient with Minitab or other statistical software, MS Word, Excel, and MS project.
-Six Sigma Certification
-ASQ CQE
-Working knowledge of 21CFR820

Trillium has been recruiting and placing professionals for over 30 years. From Fortune 100 companies to small businesses, our philosophy remains the same: to achieve excellence by providing quality employees and an uncompromising level of service. We believe in honesty, integrity, and a simple philosophy of providing value to our customers and our employees. We strive to be unsurpassed in the recruitment and placement of quality and skilled professionals. Trillium is an Equal Opportunity Employer.

Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for the employers and the California Fair Chance Act.

By applying to this job, I agree to receive electronic communications including SMS text and email regarding future opportunities, referral bonus incentives, and other promotions from Trillium. You may opt out at any time from future communications by responding STOP to any electronic communication. You may view our full privacy policy at https://trilliumstaffing.com/jobs/privacy/.

Trillium offers a comprehensive benefit package that includes the ability to participate in health insurance and retirement plans, paid holidays, state required leave, and vacation days, if applicable. Trillium’s offerings are dependent on the state in which the assignment is located, length of time worked, and may change depending on assignment. Benefit packages for direct hire placements vary based on the client company.

 

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Our intentions are to fill job vacancies as quickly as possible with qualified candidates. We are always accepting applications if a time sensitive job has an application deadline it is noted in the job description. Click on "Apply" to begin the apply process.