Jobs
>
Marquand

    Validation Engineer - Indianapolis, United States - Integration International Inc

    Integration International Inc
    Integration International Inc Indianapolis, United States

    3 weeks ago

    Integration International Inc. background
    Description

    Job Description:


    The Process Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process problems to maintain system readiness of both packaging equipment and data historian network.

    You will ensure site compliance and all vital activities are performed on time to keep all validated systems in a validated state.

    In this role, you will also create and implement the site's validation strategy.


    Responsibilities:
    Assess and define assigned validation projects. Liaise between engineering and quality assurance throughout validation lifecycle of packaging equipment and data historian network.
    Develop validation strategy based on URS and pFMEA.
    Writing, reviewing, and implementing project validation protocols for standard & customized systems.
    Raise discrepancies and closeout test documentation.
    Prepare validation summary reports for completed protocols.
    Conduct deviation investigations, such as validation failures, complaints, and hold investigations. To Identify & implement the appropriate corrective actions.
    Applying structured problem-solving tools, working with Operations to resolve technical issues and rationalize impact to validated state.
    Author operational guidance documents (SOP/WI/JA/FORM) and conduct trainings.
    Travel to support FAT executions.

    Partner with quality assurance team to participate in internal and external audits to defend equipment validation packages including calibration and maintenance.


    Education:
    Bachelor of Science Degree in Engineering or another scientific subject area from an accredited College or University


    Experience:


    Minimum of 3 years of validation experience in a regulated industry or equivalent validation experience that includes the development and execution of FAT, SAT, and IQ/OQ protocols required.

    Experience with DeltaV or similar automation system preferred.
    Experience working with Track wise, Maximo, and other electronic document management systems preferred.
    Experience applying Data Integrity Principles (ALCOA) as part of standard work preferred.
    Experience with computer systems validation, cleaning validation, and environmental monitoring preferred.
    Demonstrated understanding of cGMP, GDP, and regulatory requirements for automated systems, CPPs, and CQAs, pFMEAs


    Knowledge, Skills, Abilities:
    Great teammate who enjoys working on a dynamic team and making an impact

    Driven to successfully evaluate risks, opportunities, and roadblocks to make the best decisions to achieve your goals and the team's goals.

    Diligent collaborator whose comfortable influencing, informing, and instructing peers and members of the leadership team throughout all levels of the organization.

    Hands-on engineer with comfortability being present in and working in and around manufacturing areas and equipment.

    #J-18808-Ljbffr
  • Insight Global

    Validation Engineer

    3 weeks ago

    Insight Global Indianapolis, United States

    Insight Global is looking for a mechanical or electrical engineer with validation experience. Any kind of HVAC experience is a plus. Will develop documentation/blueprints/designs and sequences of operation for evaluation and validation of existing and new HVAC systems. Will devel ...

  • PSC Biotech

    Validation Engineer

    6 days ago

    PSC Biotech Indianapolis, United States

    Job Description · Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to ...

  • Insight Global

    Validation Engineer

    16 hours ago

    Insight Global Indianapolis, United States

    Insight Global is looking for a mechanical or electrical engineer with validation experience. Any kind of HVAC experience is a plus. Will develop documentation/blueprints/designs and sequences of operation for evaluation and validation of existing and new HVAC systems. Will devel ...

  • PSC Biotech

    Validation Engineer

    2 weeks ago

    PSC Biotech Indianapolis, United States

    Job Description · Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to ...

  • Infojini

    Senior Validation Engineer

    3 weeks ago

    Infojini Indianapolis, United States

    Job Title – Senior Validation EngineerLocation – Indianapolis, IN 46221Duration – 9+ months contract to hire positionShift Hours – Mon – Fri 8AM to 5PM · Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying. · ...

  • TekWissen ®

    Senior Validation Engineer

    3 weeks ago

    TekWissen ® Indianapolis, United States

    Position: Senior Validation Engineer · Location: Indianapolis, IN · Duration: 9 Months · Job Type: Contract · Work Type: Onsite · Shift: Monday to Friday - 08:00 AM to 05:00 PM · Pay Rate: 30-35/Hourly/W2 · Overview: · TekWissen Group is a workforce management provider throug ...

  • Maxonic, Inc.

    Sr. Validation Engineer

    2 weeks ago

    Maxonic, Inc. Indianapolis, United States

    Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Validation Engineer. · Job Description: · Position: Sr. Validation Engineer · Location: Indianapolis, IN · Duration: 9+ months · Work Schedule: ONSITE ...

  • Maxonic

    Sr. Validation Engineer

    1 week ago

    Maxonic Indianapolis, United States

    Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Validation Engineer. · Job Description: · Position: Sr. Validation Engineer · Location: Indianapolis, IN · Duration: 9+ months · Work Schedule: ON ...

  • Tekwissen

    Senior Validation Engineer

    3 weeks ago

    Tekwissen Indianapolis, United States

    Position: Senior Validation Engineer · Location: Indianapolis, IN · Duration: 9 Months · Job Type: Contract · Work Type: Onsite · Shift: Monday to Friday - 08:00 AM to 05:00 PM · Pay Rate: 30-35/Hourly/W2 · Remember to check your CV before applying Also, ensure you read th ...

  • Integrated Resources

    Senior Validation Engineer

    1 week ago

    Integrated Resources Indianapolis, United States

    Integrated Resources, Inc · Indianapolis, IN (Onsite) · Full-Time · Intent to convert after 90 days based on performance. · Pharmaceutical experience required. · Monday to Friday 8 am to 5 pm · Job Description: · How will you make an impact? · The Process Validation Engineer w ...

  • Della Infotech

    Senior validation engineer

    3 weeks ago

    Della Infotech Indianapolis, United States

    Job Title: · Senior Validation Engineer · Duration: 9 Months Contract · Location: Indianapolis, IN · Pay rate: $ 40/hr · Intent to convert after 90 days based on performance. · Pharmaceutical experience is required. · The Process Validation Engineer will mentor and support ...

  • PSC Biotech

    Senior Validation Engineer

    1 day ago

    PSC Biotech Indianapolis, United States

    Job Description · PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to skyrocket our ...

  • PSC Biotech

    Senior Validation Engineer

    6 days ago

    PSC Biotech Indianapolis, United States

    Job Description · Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to ...

  • CAI

    Senior Validation Engineer

    4 weeks ago

    CAI Indianapolis, United States

    We are seeking CQV Engineers with 4-8 years' experience and we can assist with relocation costs. · Position Description: · The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and ...

  • TekWissen ®

    Validation Engineer

    2 weeks ago

    TekWissen ® Indianapolis, United States

    Position: Validation Engineer (Pharmaceutical) · Location: Indianapolis, IN · Duration: 9 Months · Job Type: Contract · Work Type: Onsite · Shift: Monday to Friday - 08:00 AM to 05:00 PM · Pay Rate: 30-35/Hourly/W2 · Overview: · TekWissen Group is a workforce management provider ...

  • Integration International Inc

    Validation Engineer

    4 weeks ago

    Integration International Inc Indianapolis, United States

    Job Details: · Title: Senior Validation Engineer · Location: Indianapolis, IN 46221 · Duration: 09 months (Intent to convert after 90 days based on performance.) · Monday to Friday 8am to 5pm · Pharmaceutical experience required. · Job Description: · How will you make an ...

  • PACIV

    Validation Engineer

    3 weeks ago

    PACIV Indianapolis, United States

    PACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis). ...

  • Insight Global

    Validation Engineer

    2 weeks ago

    Insight Global Indianapolis, United States

    Insight Global is looking for a mechanical or electrical engineer with validation experience. Any kind of HVAC experience is a plus. Will develop documentation/blueprints/designs and sequences of operation for evaluation and validation of existing and new HVAC systems. Will devel ...

  • Procom

    Validation Engineer

    3 weeks ago

    Procom Indianapolis, United States

    Deviation Investigator Intro: · As a Deviation Investigator, you will play a critical role in maintaining the integrity and compliance of validation processes within a regulated environment. Your expertise in engineering, scientific, or maintenance disciplines will be pivotal in ...

  • Katalyst HealthCares & Life Sciences

    Validation Engineer

    4 weeks ago

    Katalyst HealthCares & Life Sciences Indianapolis, United States

    Responsibilities: · Determine project scope and strategy with client groups and other stakeholders to execute small and large capital projects in a cGMP environment. · Participate in the development of the following Validation efforts: Validation Planning, Protocol Generation, ...