Talent.com
Validation Engineer
Validation EngineerFresenius Kabi USA, LLC • Melrose Park, IL, United States
Validation Engineer

Validation Engineer

Fresenius Kabi USA, LLC • Melrose Park, IL, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Job Summary

Salary : $65,000 to $80,000

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.

Responsible for providing technical support to operations in terms of equipment / system / process initial validation and equipment / system / process requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000). The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Weekends and Off-shift hours are periodically required.

Responsibilities

Responsibilities :

  • Schedules and executes equipment requalifications per Standard Operating Procedures (SOPs).
  • Coordinates and communicates all testing with affected functional groups and evaluates test results.
  • Assembles and composes the final report and circulates for approval
  • Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. Presents results to Regulatory Agency when necessary.
  • Programs and operates department analytical instruments (such as temperature / humidity dataloggers) to perform controlled temperature / humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
  • Develops / improves validation programs as needed to remain current with cGMPs and industry standards.
  • Schedules and executes HEPA Filter and Critical Area (Class 100) testing per SOP. Programs and operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
  • Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
  • All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements :

  • Bachelor's degree in a Science or Engineering field of study required
  • Minimum of one year relevant work experience in a cGMP regulated industry.
  • Experience generating reports, deviations or other technical documents.
  • Experience with Installation, Operational and Performance Qualification protocol generation and execution strongly preferred.
  • Analytical datalogger programming, operating, troubleshooting, data-collecting preferred.
  • PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency
  • Knowledge of cGMP room classifications, HEPA filter testing and Airflow Pattern testing tools and techniques.
  • Knowledge of cGMP Cleaning Validation requirements and techniques
  • Knowledge of cGMP Process and Product Validation requirements and techniques.
  • Additional Information

    We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution , andwellness program.

    Fresenius Kabi is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

    serp_jobs.job_alerts.create_a_job

    Validation Engineer • Melrose Park, IL, United States

    Job_description.internal_linking.related_jobs
    Design Validation Manager

    Design Validation Manager

    Baxter • Round Lake, IL, US
    serp_jobs.job_card.full_time
    This is where you save and sustain lives.At Baxter, we are deeply connected by our mission.No matter your role at Baxter, your work makes a positive impact on people around the world.You'll feel a ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Firmware Engineer

    Senior Firmware Engineer

    Aspinity • Chicago, IL, United States
    serp_jobs.job_card.full_time
    The United States Air National Guard’s 131st Rescue Squadron recently relied on Somewear’s ATAK integration to coordinate a civilian rescue 1,200 miles off the U. Because our platform provided consi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    FPGA Design Engineer

    FPGA Design Engineer

    Eagle Seven • Chicago, IL, US
    serp_jobs.job_card.full_time
    FPGA Design / Verification Engineer.HDL solutions for our high frequency, low latency electronic trading systems.The candidate will support new and existing solutions while helping define design as...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Welding Engineer

    Senior Welding Engineer

    Scot Forge • Spring Grove, IL, US
    serp_jobs.job_card.full_time
    Scot Forge is a 130-year-old, 100% employee-owned company that manufactures custom open die and rolled ring forgings.At Scot Forge, we help our customers succeed in their most critical initiatives ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Entry Level Structural Engineer

    Entry Level Structural Engineer

    10-4 Engineering, PLLC • Chicago, IL, United States
    serp_jobs.job_card.full_time
    Engineering PLLC is seeking an Entry Level Structural Engineer.Chicago-based engineering firm recently founded by three licensed structural engineers : Hemal Patel, Gary Powell and Vinod Patel.Hemal...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Engineer

    Engineer

    Tavern Research • Chicago, Illinois, United States, 60601
    serp_jobs.job_card.full_time
    Office : 3 days / week in South Loop office.Reports to : Chief Technology Officer.Salary Range : $85,000 - $120,000 & equity. Tavern Research is a political tech startup that builds tools and insights to...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Validation Lead-Chicago, IL

    Validation Lead-Chicago, IL

    Staffing • Chicago, IL, US
    serp_jobs.job_card.full_time
    Interview Process : Phone Followed by F2F.US Citizen, Green Card and GC EAD Required.Job Description : Technical / Functional Skills Expert knowledge of and experience with regulatory agency regulation...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Validation Lead-Waukegan, IL

    Validation Lead-Waukegan, IL

    Staffing • Waukegan, IL, US
    serp_jobs.job_card.full_time
    Location : Waukegan, IL Duration : 12 Months Rate : DOE All Visa status who are authorized to work in US are accepted and no sponsorship available for third party C2C Job Description 8-12 years of exp...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Validation Lead - Waukegan, IL

    Validation Lead - Waukegan, IL

    Staffing • Waukegan, IL, US
    serp_jobs.job_card.full_time
    USC / GC and EAD preferred, no third party agencies.FDA mandated / Quality Systems and Client Validation / SLC background can be other Life Sciences.serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Quality Engineer

    Quality Engineer

    Intellectt Inc • North Chicago, IL, United States
    serp_jobs.job_card.temporary
    Intellectt Inc is hiring for Quality Engineer for its fortune Medical Device client.Duration : 6 months contract (extension possibility). Responsible for representing QA on cross-functional teams and...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Entry Level Engineer

    Entry Level Engineer

    Messina Talent Advisors • Lisle, IL, US
    serp_jobs.job_card.full_time
    Seeking a motivated Entry-Level Engineer to support our client’s technical team in a hands-on contract role based in Lisle. This position offers valuable exposure to engineering validation pro...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Quality Engineer, Wieland Thermal Solutions, Inc., Wheeling, IL

    Quality Engineer, Wieland Thermal Solutions, Inc., Wheeling, IL

    Wieland Group • Wheeling, IL, United States
    serp_jobs.job_card.full_time
    Quality Engineer, Wieland Thermal Solutions, Inc.Quality Engineer, Wieland Thermal Solutions, Inc.Responsible for ensuring products meet quality standards for the company.This will involve maintain...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Fabrication Engineer

    Fabrication Engineer

    MJ Celco • Schiller Park, IL, USA
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Engineer plans, organizes and directs engineering to meet company objectives for design, new product development and improvement of existing product lines by performing the following duties : .Provid...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Paper Converting Process Engineer

    Paper Converting Process Engineer

    TRS Staffing Solutions • Chicago, IL, US
    serp_jobs.job_card.full_time
    Our client, a global leading manufacturer of food packaging products, is seeking a Sr.Plastics Process Engineer to join their growing team in Mason, MI. As a Plastics Process Engineer, you'll pl...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Engineer I

    Engineer I

    cGMP Consulting • Chicagoland, IL, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilitie...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Entry Level Structural Engineer (Chicago)

    Entry Level Structural Engineer (Chicago)

    10-4 Engineering, PLLC • Chicago, IL, US
    serp_jobs.job_card.part_time
    Engineering PLLC is seeking an Entry Level Structural Engineer.Chicago-based engineering firm recently founded by three licensed structural engineers : Hemal Patel, Gary Powell and Vinod Patel.Hemal...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Welding Engineer

    Senior Welding Engineer

    SCOT FORGE • Spring Grove, IL, US
    serp_jobs.job_card.full_time
    Scot Forge is a 130-year-old, 100% employee-owned company that manufactures custom open die and rolled ring forgings.At Scot Forge, we help our customers succeed in their most critical initiatives ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Process Engineer

    Process Engineer

    BrightFarms Inc • Yorkville, IL, US
    serp_jobs.job_card.full_time
    BrightFarms is The Place to Grow!.At BrightFarms, we’re on a mission to revolutionize the way leafy greens are grown.But we don’t just want to grow great tasting greens, we want them to...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Level IV Systems Engineer

    Level IV Systems Engineer

    Syscon Inc • Chicago, IL, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Level IV Systems Engineer Location : Remote with periodic onsite visits (Chicago area) | Type : Full-Time Are you a seasoned IT professional with deep knowledge of network infrastructure, server mana...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Engineer II

    Engineer II

    Tavern Research • Chicago, Illinois, United States, 60601
    serp_jobs.job_card.full_time
    Reports to : Tavern Labs Director of Engineering.Salary Range : $146,500-$172,000 + Equity.Tavern Research is a political tech startup that builds tools and insights to help our customers win electio...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30