Jobs
>
Leawood

    Validation Engineer/Specialist II - Leawood, United States - IPS-Integrated Project Services, LLC

    IPS-Integrated Project Services, LLC
    IPS-Integrated Project Services, LLC Leawood, United States

    1 week ago

    Default job background
    Description

    Job Description:

    At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer II to join our talented team at our office located in Leawood, Kansas.

    Performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone commissioning services for non-FDA regulated clients.

    What You'll Do

    • Write C/Q/V documents following established standards and templates, including but not limited to the following:
      • Commissioning Forms
      • C/Q/V Protocols and Summary Reports
      • Standard Operating Procedures
      • Impact Assessments
      • Specifications (URS/FRS/DDS)
      • FATS/SATs
    • Perform field/site activities including, but not limited to, the following:
      • Attend and witness FATs and SATs as a representative of IPS clients.
      • Execution of commissioning forms and witnessing vendor start-up and testing.
      • Execution of C/Q/V protocols.
      • Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
      • Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
      • Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
      • Work with the Project Delivery department or CM for start-up and vendor testing.
      • Witness and troubleshoot as required.
    • C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
    • Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services
    • Perform work to meet IPS budget requirements and quality standards.
    • Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested.

    Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights

    Qualifications & Requirements:
    • 2+ years of relevant experience.
    • Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
    • Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).

    Preferred Qualifications

    • Associate or Bachelor's degree in a related field.
    • Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
    • General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.

    Context and Safety

    • This position will have up to 100% travel, or as required by the assigned project.
    • You may be assigned to the client site for an extended period.
    • Overnight travel or staying in the city of the Clients location is possible depending on the assignment.
    • Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
    • You may visit active construction sites and will be required to take site safety training and adhere to site safety rules.
    • This position is a safety-sensitive position.
    • The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
    About Us:

    IPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products. Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industries. With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East.

    Specialties

    Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.

    All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.

    Attention Search Firms / Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via email, the Internet, or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.

    #LI-RR1

  • Compli, LLC

    Cleaning Validation Engineer

    5 days ago

    Compli, LLC Lenexa, United States

    Job Description · Job Description · One (1) person minimum 4 years experience where experience is heavy on Aseptic Fill Line Parts Washer Commissioning, IQ, OQ and PQ, Parts & cycle development and CIP Validation activities on Tanks that include Cleaning cycle development and v ...

  • Gahagan & Bryant Associates Inc

    Senior Cleaning Validation Engineer

    1 week ago

    Gahagan & Bryant Associates Inc Lenexa, United States

    Job Summary: · The Senior Cleaning Validation Engineer will be responsible for providing validation expertise and leadership, coordinating and achieving project deliverables, writing and reviewing protocols, executing protocol execution, and tracking and reporting on cleaning va ...

  • GBA

    Senior Cleaning Validation Engineer

    1 week ago

    GBA Lenexa, United States

    Job Summary: · The Senior Cleaning Validation Engineer will be responsible for providing validation expertise and leadership, coordinating and achieving project deliverables, writing and reviewing protocols, executing protocol execution, and tracking and reporting on cleaning val ...

  • Cascade Innovations

    Training for Civil Engineering Specialist

    1 week ago

    Cascade Innovations Blue Springs, United States

    Our Benefits:At Sandmann GmbH, our 2-year apprenticeship program for road construction civil engineering offers a diverse, varied, and hands-on training close to home. · We offer a competitive salary according to the collective bargaining agreement: · 1st year: 880.00€ · 2nd year ...

  • L3Harris Technologies

    Specialist, Logistics Systems Engineer

    6 days ago

    L3Harris Technologies Park City, United States Temps plein

    Job Title – Specialist Systems Engineer - RAMS Engineer · Job Location – USA-UT-Salt Lake City · Job ID – 10820 · Job Schedule: 9/80, every other Friday off · Description · We are seeking a Reliability, Maintainability & Safety (RAMS) Engineer to be responsible for analyzing and ...

  • Quantum Ventures

    Electrical systems installer

    1 week ago

    Quantum Ventures Johnson Prairie, United States

    We are looking for several electrical installation technicians (m/f/d) for our clients in Mönchengladbach and Willich. · Tasks: · Installation and maintenance of electrical systems · Performing repairs and maintenance work · Troubleshooting and resolving malfunctions · Assembly o ...

  • Crimson Enterprises

    Project Engineer Qualification

    1 week ago

    Crimson Enterprises Overland, United States

    Discover an Exciting Role · Exyte is a global leader in the planning, development, and project execution of facilities for the high-tech industry, with a history of over a hundred years and 7,400 employees. · The position of Project Engineer in the Pharma/Food sector with a focus ...

  • Providence

    Provider Contracts Specialist

    1 week ago

    Providence Mission Hills, United States

    **Description** · Under the general direction of the Manager, Patient Benefits, the Physician Contracts Specialist is accountable for Contract administration, interpreting contract requirements from Corporate Contracting for the daily operations of the Claims system testing, to i ...

  • Aurora Solutions

    Building draftsman

    2 weeks ago

    Aurora Solutions Overland Park, KS, United States Freelance

    As a Construction Draftsman (m/f/d), you have the opportunity to contribute to the design and implementation of exciting construction projects in Overland Park, KS. Whether it is the construction of a new residential building, the planning of industrial buildings, or the restorat ...

  • Roche

    Field Engineering Specialist

    1 week ago

    Roche Kansas City, United States Full time

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we ...

  • Roche

    Field Engineering Specialist

    30 minutes ago

    Roche Kansas City, United States Full time

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we ...

  • Infinity Ventures

    Warehouse Logistics Manager

    1 week ago

    Infinity Ventures Grandview, United States

    Join us at Finsterwalder · For over 80 years, the Finsterwalder Group has been providing transport, logistics, warehouse, and fulfillment solutions as a service for national and international clients. Sustainable business growth and creative solutions for our clients are what set ...

  • 22nd Century Technologies Inc.

    GIS Systems Engineering Specialist

    1 week ago

    22nd Century Technologies Inc. Kansas City, United States

    Title: GIS Systems Engineering Specialist · Client: DoD/Federal · Location: Kansas City, MO · Roles and Responsibilities: The Senior GIS Systems Engineer is responsible for the design, build, automation, support, security, management, and optimization of GIS systems, such as such ...

  • BlueNova Industries

    Software developer C/C++

    1 week ago

    BlueNova Industries Grandview, United States

    Are you dreaming of exciting projects in leading high-tech companies? Are you looking for new challenges in fields such as mechanical engineering, vehicle technology, or alternative energies? Develop globally recognized "Made in Germany" solutions that shape the innovations of to ...

  • 22nd Century Technologies

    GIS Systems Engineering Specialist

    2 weeks ago

    22nd Century Technologies Kansas City, United States

    Title: GIS Systems Engineering Specialist · Client: DoD/Federal · Location: Kansas City, MO · Roles and Responsibilities: The Senior GIS Systems Engineer is responsible for the design, build, automation, support, security, management, and optimization of GIS systems, such as s ...

  • Horizon Technologies

    Sales Engineer

    1 week ago

    Horizon Technologies Grandview, United States

    **About W. Müller GmbH & Co. KG: ** · As one of the largest specialists for roofing and solar in southern Germany, we offer services and solutions of a recognized family business, where innovation has been a tradition for years. · What do we offer? · Diverse and challenging field ...

  • Honeywell

    Sr Engineering Support Specialist

    2 weeks ago

    Honeywell Kansas City, United States Full time

    Summary · This position performs a full range of complex engineering support assignments requiring significant knowledge of manufacturing, business and project management processes. · Duties and Responsibilities · This position requires the ability to work independently at a high ...

  • Honeywell

    Sr Engineering Support Specialist

    3 days ago

    Honeywell Kansas City, United States

    Summary · This position performs a full range of complex engineering support assignments requiring significant knowledge of manufacturing, business and project management processes. · Duties and ResponsibilitiesThis position requires the ability to work independently at a high le ...

  • FM Global

    Sr. Consultant Engineer

    4 days ago

    FM Global Kansas City, United States Full time

    FM Global is a leading property insurer of the world's largest businesses, providing more than one-third of FORTUNE 1000-size companies with engineering-based risk management and property insurance solutions. FM Global helps clients maintain continuity in their business operation ...

  • Rich Products Corporation

    Environmental Health

    1 day ago

    Rich Products Corporation Missouri City, United States

    Rich's, also known as Rich Products Corporation, is a family-owned food company dedicated to inspiring possibilities. From cakes and icings to pizza, appetizers and specialty toppings, our products are used in homes, restaurants and bakeries around the world. Beyond great food, o ...