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Commissioning engineer serp_jobs.h1.location_city

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Commissioning engineer • gainesville fl

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Manufacturing Engineer / validation process engineer

Manufacturing Engineer / validation process engineer

cGxPServeGainesville, Florida, USA
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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 procedural ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Software Engineer

Software Engineer

Seacoast National BankGainesville, FL, United States
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Location : This position can be located at any Seacoast office within Florida.The software engineer will play an integral role in the execution of the bank's application and API development initiati...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Maintenance Engineer

Maintenance Engineer

Pyramid Global HospitalityGainesville, FL, US
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Welcome to Pyramid Global Hospitality, where people come first.As a company that values its employees, Pyramid Global Hospitality is dedicated to creating a supportive and inclusive work environmen...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
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_variable_days
Mechanical Engineer

Mechanical Engineer

AYR WellnessGainesville, Florida
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AYR Wellness is a publicly traded, multi-state cannabis company with more than 85 dispensaries.We are one of the largest scale producers of high-quality cannabis in the U.People are at the heart of...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Civil Design Engineer

Civil Design Engineer

JBProGainesville, FL, US
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Founded in 1995, JBPro is one of the leading site development design and consulting firms in North Florida.Approaching our fourth decade of service, we remain dedicated to our passio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Product Engineer

Product Engineer

ActalentGainesville, FL, US
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Technical Leadership : Serve as the technical lead for assigned product line(s), ensuring engineering excellence and innovation. Cross-Department Coordination : Collaborate with Production, Purchasing...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
Drainage Engineer

Drainage Engineer

VolkertGainesville, FL, US
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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
Software Engineer

Software Engineer

Seacoast BankGainesville, FL , US
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Location : This position can be located at any Seacoast office within Florida.The software engineer will play an integral role in the execution of the bank’s application and API development initiati...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Manufacturing Engineer

Manufacturing Engineer

ExactechGainesville, FL, US
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Create and maintain the lowest cost, highest quality machining & manufacturing processes, tooling and supporting documentation for all parts produced. Support shop floor to deliver business resu...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Supplier Quality Engineer

Supplier Quality Engineer

Intellectt IncGainesville, FL, United States
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Job Description & Key Responsibilities : .ISO 13485, FDA, CFR 21 Part 820.CAPA closure and quality improvements.Supplier Initiated Change Requests (DCR, ECR, MCR). Supplier Audit Non-Conformities.MSA,...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
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
Outside Plant Engineer

Outside Plant Engineer

IQ FiberGainesville, FL, US
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A Smarter Career Choice Because the internet is now the heartbeat of our homes and an essential tool for business, it should run without interruption or stress. IQ Fiber was created to offer 100% fi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Roadway Engineer

Roadway Engineer

Kimley-HornGainesville, FL, US
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Civil Engineer Job In Ocala, Fl.Kimley-Horn's Ocala, FL office is seeking a Civil Engineer with 4+ years of experience to join their Roadway team! This is not a remote position.Collaborate with the...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
Manufacturing Engineer / validation process engineer

Manufacturing Engineer / validation process engineer

cGxPServeGainesville, Florida, USA
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Responsibilities :

  • 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 process improvements and equipment modifications.
  • 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.

Requirements :

  • Bachelors or masters degree in mechanical engineering Biomedical Engineering or related field.
  • 5 years of experience in medical device manufacturing with hands-on experience in CNC Machining and DCM.
  • Strong understanding of FDA ISO 13485 and GMP requirements.
  • Proficiency in statistical analysis tools (e.g. Minitab JMP).
  • Experience with QMS systems and documentation practices.
  • Excellent analytical problem-solving and communication skills.
  • Key Skills

    Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

    Employment Type : Full-time

    Experience : years

    Vacancy : 1