Validation Engineer

The Manufacturing Validation Engineer is responsible for reviewing and troubleshooting manufacturing validations, supporting or leading daily initiatives, and collaborating with cross-functional teams to achieve production goals. This role involves innovative problem-solving and expertise in validations, process improvement, and equipment recommendations to ensure quality, delivery, and cost-effectiveness. The position requires hybrid work (3 days onsite) and 25% travel, including international trips to the Dominican Republic.

• Collaborate with R&D, Quality, Production, Regulatory, and Supply Chain teams on complex projects to ensure successful outcomes.
• Develop and execute validation protocols for processes and equipment.
• Generate innovative solutions to support validation activities and continuous improvement initiatives.

• Conduct technology development, process studies, Six Sigma initiatives, and testing of materials or products.
• Assess feasibility and soundness of proposed engineering evaluations, tests, or equipment.
• Summarize and analyze test results, preparing detailed reports and communicating findings effectively.

• Identify and implement process improvement techniques to address complex challenges.
• Perform risk assessments and coordinate change reviews to enhance manufacturing efficiency.

• Lead cross-functional project teams, documenting goals and progress, and recommending adjustments as needed.
• Manage and complete complex Capital Equipment Request Authorizations (CERAs).
• Provide training, development, and work direction to operators, technicians, and engineers.

• Review and maintain validation documentation, including TMVs (Test Method Validations) and manufacturing development records.
• Ensure compliance with quality standards and regulatory requirements.

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  Education:

  
  
  
  
  • Bachelor's degree with 4-8 years of experience or Master's degree with 3-6 years of experience.
  
  
  
  
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  Skills & Experience:

  
  
  
  
  • Strong background in validations, documentation reviews, and process development.
  • Expertise in risk assessments, change reviews, and manufacturing validation.
  • Experience with CM (Contract Manufacturers) or OEMs, particularly Jabil suppliers.
  • Familiarity with Six Sigma methodologies and process improvement techniques.
  • Proficiency in preparing detailed reports and managing cross-functional teams.
  
  
  
  
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  Additional Requirements:

  
  
  
  
  • Travel: Up to 25%, including one week per month in the Dominican Republic (passport required).
  • Hybrid work arrangement: 3 days onsite, with flexibility for the third day.
  • Proficient in virtual collaboration tools (Teams video interviews).
  
  
  
  

• Experience with supplier management and validation oversight.
• Strong analytical and problem-solving skills.
• Ability to lead projects and drive cross-functional collaboration effectively.

• Opportunity to work on innovative and impactful projects.
• Collaborative, hybrid work environment with potential for temp-to-hire based on performance and budget.
• Exposure to international manufacturing operations and supplier management.

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.