Talent.com
Validation Engineer II

Validation Engineer II

IPS-Integrated Project ServicesIndianapolis, IN, United States
13 days ago
Job type
  • Full-time
Job description

Job Description

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented CQV Engineer II to join our team at our office located in _____________.

In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also follow IPS and client standards and requirements, overall good industry practices for C / Q / V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients.

Additional Responsibilities

  • 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 of 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.
  • Primary responsibilities include 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 our dynamic team that creates world-class designs for our clients, and propel your career to new horizons!

Qualifications & Requirements

  • Bachelor of Science in Engineering.
  • 2+ years of relevant work experience.
  • This is an entry-level position.
  • Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
  • Preferred Qualifications

  • 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 & Safety

  • This position will have up to 100% travel to the site, or as required by the assigned project.
  • You may be assigned to a client site for an extended period.
  • Overnight travel or staying in the city of the client’s 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.
  • All interviews are conducted either in person or virtually, with video required .

    About Us

    IPS , a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That’s only possible when we care as much as our clients do.

    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.

    Connect With Us!

    If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!

    Create a job alert for this search

    Validation Engineer • Indianapolis, IN, United States

    Related jobs
    • Promoted
    Maintenance Supervisor - 2nd Shift

    Maintenance Supervisor - 2nd Shift

    MCKESSONPlainfield, IN, United States
    Full-time
    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare.We are known for delivering insights, products, and services that make quality care more accessibl...Show moreLast updated: 30+ days ago
    • Promoted
    X-Ray Technologist - Immediate Interviews

    X-Ray Technologist - Immediate Interviews

    Fast Pace Health CareersGreenfield, Indiana, US
    Full-time
    Posting Title : X-Ray Technologist Overview : At Fast Pace Urgent Care, X-Ray Techs provide clinical and administrative support essential for effective patient care under the direct supervision of a ...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Operator II

    Operator II

    Volt Workforce SolutionsWestfield, IN, US
    Full-time
    Volt is immediately hiring for a.Medical Device Assembler II at Westfield, IN.Job Roles and Responsibilities : .Assembles medical devices and related components. Performs visual inspection and precisi...Show moreLast updated: 2 hours ago
    • Promoted
    DC Supervisor

    DC Supervisor

    Tractor Supply CompanyPendleton, IN, US
    Full-time +1
    SHIFT : 10B Tuesday-Friday 4 : 30PM-2 : 30AM.This position is responsible for leading and developing a team of hourly team members. This position is also responsible for establishing daily production goa...Show moreLast updated: 30+ days ago
    • Promoted
    General Lab Supervisor in Indiana

    General Lab Supervisor in Indiana

    KA Recruiting Inc.Zionsville, IN, US
    Full-time +1
    Looking for a Lab Management job?.My name is Leah and I'm a healthcare recruiter, I'm here to help!.Shifts : 2 : 00pm - 10 : 30pm w / rotating weekends / holidays. Full, comprehensive benefits packa...Show moreLast updated: 30+ days ago
    • Promoted
    Laboratory Supervisor - Indiana

    Laboratory Supervisor - Indiana

    KA Recruiting Inc.Indianapolis, IN, US
    Full-time +1
    NEW Medical Laboratory Supervisor opening in the Indianapolis, Indiana area for permanent, direct hire! This client is actively interviewing!. Full time, permanent Supervisor opening.Full, comprehen...Show moreLast updated: 30+ days ago
    • Promoted
    X-Ray Technologist - Sign-On Bonus

    X-Ray Technologist - Sign-On Bonus

    Fast Pace Health CareersMartinsville, Indiana, US
    Full-time
    Posting Title : X-Ray Technologist Overview : At Fast Pace Urgent Care, X-Ray Techs provide clinical and administrative support essential for effective patient care under the direct supervision of a ...Show moreLast updated: 30+ days ago
    • Promoted
    X-Ray Tech or X-Ray Technologist in Indiana

    X-Ray Tech or X-Ray Technologist in Indiana

    KA Recruiting Inc.Franklin, IN, US
    Full-time +1
    Looking for a new X-Ray Tech job? My name is Leah and I'm a healthcare recruiter, I'm here to help!.I have an awesome X-Ray Tech role available near Franklin, Indiana!.Full, comprehensive b...Show moreLast updated: 30+ days ago
    • Promoted
    Laboratory Supervisor in Indiana

    Laboratory Supervisor in Indiana

    KA Recruiting Inc.Zionsville, IN, US
    Full-time +1
    Looking for an MT / MLT Management job?.My name is Leah and I'm a healthcare recruiter, I'm here to help!.Shift : 2 : 00pm - 10 : 30pm, w / rotating weekends + holidays. Full, comprehensive benefits...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Validation Engineer II

    Validation Engineer II

    PACIVIndianapolis, IN, US
    Full-time
    We are seeking a detail-oriented and proactive.This role is responsible for executing and managing periodic reviews of computer systems, and driving resulting action items to completion.The ideal c...Show moreLast updated: 22 hours ago
    • Promoted
    Validation Engineer II

    Validation Engineer II

    IPS-Integrated Project ServicesIndianapolis, IN, United States
    Full-time
    At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically comple...Show moreLast updated: 9 days ago
    Analyst 2 - Validation

    Analyst 2 - Validation

    eTeam IncMooresville, Indiana, United States
    Full-time
    Quick Apply
    Own requirements gathering process and facilitate discussions with business and technical team to manage enhancement flow. Coordinate and Execute BST & UAT testing leveraging a strong understand...Show moreLast updated: 30+ days ago
    • Promoted
    Float X-Ray Technologist

    Float X-Ray Technologist

    Fast Pace HealthGreenfield, IN, US
    Full-time
    Posting Title : Float X-Ray Technologist Overview : .Fast Pace Health strives to provide a best in class patient experience in every interaction. We are seeking a highly-skilled, experienced X-Ray Tech...Show moreLast updated: 16 days ago
    • Promoted
    GI | Indianapolis Area | Great Pay and Established Group

    GI | Indianapolis Area | Great Pay and Established Group

    Jackson Physician SearchGreenfield, US
    Full-time
    Please contact for more information : .Show moreLast updated: 27 days ago
    • Promoted
    Lab Supervisor or Laboratory Supervisor in Indiana

    Lab Supervisor or Laboratory Supervisor in Indiana

    KA Recruiting Inc.Zionsville, IN, US
    Full-time +1
    Searching for a new Lab Leadership job? My name is Leah and I'm a healthcare recruiter, I'm here to help!.I have an amazing Lab Supervisor position available near Zionsville, Indiana!.Full,...Show moreLast updated: 30+ days ago
    Sr. Quality Engineer, Validation

    Sr. Quality Engineer, Validation

    Cardinal HealthUSA, Indiana, Indianapolis
    Full-time
    Cardinal Health offers a wide variety of benefits and programs to support health and well-being.Medical, dental and vision coverage. Access to wages before pay day with myFlexPay.Flexible spending a...Show moreLast updated: 30+ days ago
    • Promoted
    X-Ray Technologist

    X-Ray Technologist

    Fast Pace Health CareersMartinsville, Indiana, US
    Full-time
    Posting Title : X-Ray Technologist Overview : At Fast Pace Urgent Care, X-Ray Techs provide clinical and administrative support essential for effective patient care under the direct supervision of a ...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    DC Supervisor

    DC Supervisor

    LinkUpPendleton, IN, US
    Full-time +1
    Overall Job Summary SHIFT : 10B Tuesday-Friday 4 : 30PM-2 : 30AM This position is responsible for leading and developing a team of hourly team members. This position is also responsible for establishing ...Show moreLast updated: 21 hours ago