Jobs
>
Marquand

    Senior Validation Engineer - Indianapolis, United States - Infojini

    Infojini
    Infojini Indianapolis, United States

    1 month ago

    Show more Collapse job
    Default job background
    Description

    Job Title Senior Validation Engineer

    Location Indianapolis, IN 46221

    Duration 9+ months contract to hire position

    Shift Hours Mon Fri 8AM to 5PM

    How will you make an impact?

    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 sites validation strategy.

    What will you do:

    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, work 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

    Minimum Education and Experience:

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

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

    Experience with DeltaV or similar automation system preferred.

    Experience working with Trackwise, 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 teams 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.

    Company Overview:

    Infojini Consulting is a Staffing and Recruitment company and incorporated in Baltimore, MD.

    Infojini caters various hospitals, health & wellness centers, pharmacy, and medical facilities over fifty states across the United States.


    We have other current jobs related to this field that you can find below

  • Performance Validation

    Validation Engineer

    5 days ago


    Performance Validation Indianapolis, United States

    About Us · Here at Performance Validation, Inc (PV) we have been providing Commissioning, Qualification, and Validation services to the life science industries for 35 years We are a 100% employee owned company with teams in Indiana, Michigan, Illinois, Kansas, Washington, and Nor ...

  • 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 ...


  • 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 ...


  • PACIV Indianapolis, United States

    PACIV, a global leader in industrial automation solutions with offices in Puerto Rico, United States, and Ireland, and servicing the Life Sciences, F&B and Utilities industries is looking for a full-time employed Senior Validation Engineer based at our USA office (Indianapolis) ...


  • 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 ...


  • 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 ...


  • Thermo Fisher Scientific Indianapolis, United States

    Job Description · As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and s ...


  • LanceSoft Indianapolis, United States

    How will you make an impact?Intent to convert after 90 days based on performance. · Pharmaceutical experience required. · Monday to Friday 8am to 5pm · The Process Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process pro ...


  • 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 ...


  • Project Farma Indianapolis, United States

    This role can involve up to 100% Travel · Why Precision for Medicine? · Welcome to the forefront of innovation in cutting edge patient treatments. We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science ...


  • 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 ...

  • Katalyst HealthCares & Life Sciences

    Validation Engineer

    2 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, ...


  • Cardinal Health Indianapolis, United States

    **Anticipated salary range:** $66,500 - $95,000 · **Bonus eligible:** No · **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. · + Medical, dental and vision coverage · + Paid time off plan · + Health savings account ...


  • Cardinal Health Indianapolis, United States

    Anticipated salary range: $66,500 - $95,000 · Bonus eligible: No · Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage · Paid time off plan · Health savings account (HSA) · 401k saving ...


  • CAI Indianapolis, United States

    We are seeking CQV Engineers with 8-12 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 an ...


  • Maxonic Indianapolis, United States

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


  • Yoh, A Day & Zimmermann Company Indianapolis, United States

    Job Description · Job Description Yoh is hiring a Sr. Validation Engineer for our well-established client in Indianapolois, IN. The mission with this client is to enable our customers to make the world healthier, cleaner, and safer. They run the world's largest clinical packagin ...


  • Yoh Indianapolis, United States

    Yoh is hiring a · Sr. Process Validation Engineer · for our well-established client in · Indianapolois, IN . The mission with this client is to enable our customers to make the world healthier, cleaner, and safer. They run the world's largest clinical packaging operation and t ...


  • Mindlance Indianapolis, United States

    Job Description: As part of the team, you ll Client meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global t ...


  • Insight Global Indianapolis, United States

    Our large engineering consulting client is seeking an Engineering Technician to work on Construction Projects in the Indianapolis area. They are looking to hire ASAP · Title: Engineering Technician · Location: Carmel, IN/Greater Indianapolis area · Pay Rate: · • $18-20/hr for Tec ...