Jobs
>
Marquand

    Validation Engineer - Indianapolis, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Indianapolis, United States

    3 weeks ago

    Default job background
    Description
    Roles & 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, Protocol Execution, Familiar with GAMP/GMP process, and not limited to FATs/SATs, Product validation risk assessments, IOQ's, PQ's etc.
    • Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented, and addressed by the Validation / Engineering Team
    • Directs project validation work to ensure the manufacture of high-quality product and to facilitate compliance with regulatory requirements.
    • Liaise with internal engineering project co-ordination team, consultants, subcontractors, supervisors and the general workforce involved in the project to ensure full compliance with solution requirements.
    • Basic understanding of design controls and design transfer.
    • Leading and supporting SATs.
    • Work with cross functional teams during the commissioning and validation phases of a project, ensuring clear communication and hand-off of information.
    • Help develop Validation objectives by reviewing project proposals and plans, conferring with management.
    • Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits
    • Help determine, draft, and author project cGMP documentation such as Validation Master Plans, Specific Validation Project Plans, Schedules, IQ/OQ/PQ Protocols, Final Reports, Deviations, and Investigation support.
    • Monitoring and maintaining the quality and compliance status of associated quality records.
    • Assist with the development of project schedules by studying project plans, system boundaries, and validation package deliverables; calculating time requirements; sequencing validation elements.
    • Control validation plan by reviewing documentation, protocols, procedures, and execution strategies, coordinating with vendors and team members.
    • Prepare validation reports by collecting, analyzing, and summarizing information during execution.
    • Help oversee vendor activities to include coordination and communication to ensure project efforts progress while maintaining safety.
    • Performs duties in compliance with environmental, health and safety related rules, policies or governmental regulations.
    Qualifications & Experience:
    • Bachelor's degree in engineering.
    • 8 to 15 years of experience in the in the Engineering/Manufacturing/ Scientific field with Commissioning, Qualification and Validation of Equipment (Extruders, Molds & Molding equipment, automation for manufacturing), Utilities and/or Facilities in a cGMP environment
    • Works without supervision and is Quality driven
    • GMP/cGMP change control process experience.
    • Validation/qualification process knowledge.
    • Creative thinking and problem-solving skills
    • Attention to detail.
    • Proven track record of being self-motivated and capable of working in diverse team situations with Company clients and maintaining a positive attitude towards project challenges.
    • Experience with supporting Supplier Validations, Supplier Changes, Supplier Management and Component Qualification; preferably experience with Injection Moulding, Metal forming, extrusion, automation for manufacturing.
    • Experience working in a 21CFR820 and/or ISO13485 regulated industry.

  • Insight Global

    Validation Engineer

    1 week 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 ...


  • 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 ...


  • 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 ...


  • 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 ...


  • 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 ...


  • 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 ...


  • 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) ...


  • 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 ...


  • 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 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

    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 ...

  • The International Society for Pharmaceutical Engineering Inc

    Validation Engineer

    3 weeks ago


    The International Society for Pharmaceutical Engineering Inc 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 workforc ...

  • TekWissen ®

    Validation Engineer

    3 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 ...

  • Katalyst HealthCares & Life Sciences

    Validation Engineer

    1 week 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, ...


  • 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 the clinica ...


  • 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

    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 ...


  • Katalyst HealthCares & Life Sciences Indianapolis, United States

    Responsibilities: For Automation Engineers who are assigned to validation projects and operate in the field, the engineer may participate in validation activities. · Responsible for design and implementation of key automation aspects of an equipment project, often including PLC ...