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Validation engineer • gainesville fl

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Validation Engineer

Validation Engineer

Katalyst HealthCares & Life SciencesGainesville, FL
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Protocol Review & Compliance : Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedura...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Drainage Engineer

Drainage Engineer

VolkertGainesville, FL, United States
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Are we the road to your future?.We are currently searching for an experienced.To be considered for this position, applicants musthave, at minimum, a Bachelor's of Science in Civil Engineering.Colle...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Network Engineer II

Network Engineer II

Northeast Georgia Medical CenterGainesville, Florida, USA
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Northeast Georgia Health System is rooted in a foundation of improving the health of our communities.Network Engineer II Northeast Georgia Medical Center Inc. Service the organization patients and ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
Civil Engineer

Civil Engineer

Liberty JobsGainesville, FL
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Proficient in Civil 3D software.Strong project management and communication skills.Ability to work collaboratively with multidisciplinary teams. Design and oversee civil engineering projects.Ensure ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Manufacturing Engineer

Manufacturing Engineer

Katalyst Healthcares & Life SciencesGainesville, FL, United States
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Protocol Review & Compliance : Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedura...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Entry-Level Engineer

Entry-Level Engineer

The Whiting-Turner Contracting CompanyGainesville, FL, United States
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The Whiting-Turner Contracting Company is an Equal Opportunity Employer, including the disabled and veterans.Whiting-Turner Entry-Level Engineers are team members who help manage all aspects of con...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Maintenance Engineer

Maintenance Engineer

Peachtree GroupGainesville, FL, US
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The Maintenance Engineer position is responsible for providing technical and maintenance services throughout the hotel to keep the hotel’s general equipment and systems in excellent condition.Appro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Coordinator

Validation Coordinator

LifeSouthGainesville, FL
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Job Type Full-time Description.Are you looking to make a difference in your community and help save lives? Seeking to work for a non-profit whose values include safety, teamwork, and stewardship? D...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Manufacturing Engineer

Manufacturing Engineer

Advita OrthoGainesville, FL, United States
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Senior Manager Manufacturing Engineering.Create and maintain the lowest cost, highest quality machining & manufacturing processes, tooling and supporting documentation for all parts produced.Suppor...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Civil Engineer (Professional Engineer)

Civil Engineer (Professional Engineer)

GpacGainesville, Florida, United States
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A well-established, growing engineering firm, with a location in the area, is looking for a Professional Civil Engineer.They work hard to ensure projects are planned, designed, and managed to meet ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Automation Engineer

Automation Engineer

Jones Lang LaSalle IP, Inc.Gainesville, FL, United States
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JLL empowers you to shape a brighter way.Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology f...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Maintenance Engineer

Maintenance Engineer

Property ManagementGainesville, Florida, USA
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The Maintenance Engineer position is responsible for providing technical and maintenance services throughout the hotel to keep the hotels general equipment and systems in excellent condition.Approa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Entry-Level Engineer

Entry-Level Engineer

Whiting-Turner Contracting CompanyGainesville, FL, United States
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The Whiting-Turner Contracting Company is an Equal Opportunity Employer, including the disabled and veterans.Whiting-Turner Entry-Level Engineers are team members who help manage all aspects of con...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Security Engineer

Security Engineer

City of GainesvilleGainesville, Florida, USA
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If you are an Internal City Employee Retiree or Dependent / Survivor of a City Employee please apply internally via Career Icon in your Workday account. Make a difference in the community you live in! ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Principal Backend Engineer

Principal Backend Engineer

FeathrGainesville, Florida, United States
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As the Nonprofit Marketing Platform.Feathr is purpose-built to help our customers unlock more results, time, and confidence. Feathr's software marketing platform equips nonprofits with the tools the...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Automation Engineer

Automation Engineer

JLLGainesville, FL
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JLL empowers you to shape a brighter way.Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology f...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Manufacturing Engineer

Manufacturing Engineer

Katalyst Healthcares and Life SciencesGainesville, FL, United States
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Protocol Review & Compliance : Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedura...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Software Development Engineer

Software Development Engineer

AmazonGainesville, FL, USA
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Join Amazon's engineering team and help us build innovative solutions to complex problems.As a Software Development Engineer, you will design, develop, and test software applications and services.W...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Data Engineer

Data Engineer

Digital Media SolutionsUSA, FL
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Based out of Clearwater, FL and a leading provider of technology-enabled digital performance advertising solutions, Digital Media Solutions is looking to bring aboard a. Technology team! If you are ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Validation Engineer

Validation Engineer

Katalyst HealthCares & Life SciencesGainesville, FL
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Job Description :

  • Protocol Review & Compliance : Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedural compliance.
  • Process Audits & Documentation : Conduct thorough audits of manufacturing processes to identify documentation gaps. Update Quality Management System (QMS) documents to reflect findings and ensure alignment with current standards.
  • Process Optimization : Design and execute Design of Experiments (DoE) to optimize process parameters for CNC Machining and DCM. Establish and document robust process parameters and operating windows.
  • Validation Execution : Execute or re-execute validation protocols including sample measurements and data collection. Generate comprehensive IQ, OQ, PQ reports based on validation activities.
  • Statistical Analysis : Run statistical reports to analyze process capability, variability, and performance trends.
  • Change Management : Lead and document change management activities related to Continuous Monitoring : Monitor validated process parameters to ensure equipment and processes remain in a validated state. Implement controls and corrective actions as needed to maintain compliance.
  • process improvements and equipment modifications.

Responsibilities :

  • Experience working in QMS and ERP systems.
  • Experience with IQ / OQ / PQ / TMV preferred.
  • Worked with cross functional teams.
  • Collaborate with Quality Engineering to provide manufacturing support.
  • Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness.
  • Should be experienced in medical device manufacturing assembly lines.
  • Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices.
  • Need to conduct qualification, verification, and validation activities to produce medical devices.
  • Need to be responsible for completing engineering work and contribute to new product development teams and product support, typically including the following activities : technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation.
  • Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
  • Work with CFT teams in troubleshooting problems on the production floor.
  • Requirements :

  • Bachelor's or master's degree in mechanical engineering, Biomedical Engineering, or related field.
  • years of experience in medical device manufacturing, with hands-on experience in CNC Machining and DCM.
  • Strong understanding of FDA, ISO , and GMP requirements.
  • Proficiency in statistical analysis tools (, Minitab, JMP).
  • Experience with QMS systems and documentation practices.
  • Excellent analytical, problem-solving, and communication skills.