Process Validation Engineer II

2 months ago


Littleton, United States Insight Global Full time

Insight Global is looking for a Process Validation Engineer for a Medical Device company located in Littleton, Colorado to sit onsite five days a week. The Process Validation Engineer will be dedicated to the automation equipment within the clients manufacturing facility, responsible for supporting the validation and quality engineering of various systems in a medical device manufacturing environment, and assure the equipment/system and validation records are compliant with company standards and industry practices. The position requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications. Assignments include equipment and process validation, tests method validation, process characterization, research investigations, report preparation and other activities of limited scope. Additional responsibilities include:

Carry out all aspects of a validation project, which includes: authoring and executing Validation Master Plan (VMP), Validation Plan (VP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), protocols/report in accordance with established procedures.

Perform Validation Periodic Review for various systems, including automated manufacturing equipment, computerized systems, and test equipment.

Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to determine status, gaps and corrective actions.

Provide technical input with respect to Standard Operating Procedures development. Revise or develop SOP's as required to assure that all needs are addressed, and compliance and industry standards are incorporated.

Medical Device experience
4+ years of Process Validation experience

2+ years of experience with validating automated equipment

Understanding of and adherence to GMP practices and FDA regulations.

Knowledge and ability to implement FDA or regulatory requirements as necessary



  • Littleton, United States 3D Systems Full time

    Job Title: Development Quality Engineer II Company Overview: 3D Systems Healthcare Solutions is a leading player in the medical device industry, dedicated to improving healthcare through innovation and cutting-edge technology. We are seeking a qualified Intermediate Quality Engineer to join our New Product Development (NPD) team to ensure the quality and...


  • Littleton, United States Rocket Lab Full time

    SPACE SYSTEMS Rocket Lab’s Space Systems team is responsible for every satellite and satellite component made by Rocket Lab: from complete satellites destined for missions to the Moon and Mars, to the individual components and subsystems that make up a satellite like solar panels, flight software, reaction wheels and star trackers, separation systems,...

  • Roaming Engineer II

    1 month ago


    Littleton, United States PSRTEK Inc Full time

    Job Title: Roaming Engineer II Location: Littleton, CO Responsibilities As part of the Wireless System Integration Team, this Engineer will join the team of passionate engineers with start-up spirit to deploy and debug the standalone 5G network Partner with the Technology Development team and vendors to design solutions of the network functions in a...


  • Littleton, United States Rocket Lab Full time

    SPACE SYSTEMS Rocket Lab’s Space Systems team is responsible for every satellite and satellite component made by Rocket Lab: from complete satellites destined for missions to the Moon and Mars, to the individual components and subsystems that make up a satellite like solar panels, flight software, reaction wheels and star trackers, separation systems,...

  • Process Engineer

    1 week ago


    Littleton, United States Kennedy Jenks Full time

    Founded in 1919, KJ has always looked to the future. With a talented team of professionals and a culture of continuous improvement, we deliver exceptional engineering and environmental consulting services today, with a focus on innovation and sustainability. Using new advanced analytics, technology, and tools, KJ improves designs, reduces risk, and finds...

  • Process Engineer

    3 weeks ago


    Littleton, United States Kennedy Jenks Full time

    Founded in 1919, KJ has always looked to the future. With a talented team of professionals and a culture of continuous improvement, we deliver exceptional engineering and environmental consulting services today, with a focus on innovation and sustainability. Using new advanced analytics, technology, and tools, KJ improves designs, reduces risk, and finds...

  • Process Engineer

    7 days ago


    Littleton, United States Kennedy Jenks Full time

    Founded in 1919, KJ has always looked to the future. With a talented team of professionals and a culture of continuous improvement, we deliver exceptional engineering and environmental consulting services today, with a focus on innovation and sustainability. Using new advanced analytics, technology, and tools, KJ improves designs, reduces risk, and finds...


  • Littleton, United States Terumo BCT Full time

    Requisition ID: 32032 At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative...


  • Littleton, United States ZAP Engineering & Construction Services, Inc. Full time

    TITLE: Process Engineering Supervisor DEPARTMENT: Engineering REPORTS TO: Director, Process Engineering FLSA: Exempt, Full-Time WORK SCHEDULE: M-F 8AM to 5PM TRAVEL REQUIRED: Up to 20% LOCATION: Lakewood, Colorado MANAGEMENT: Yes EEO: Professionals JOB FAMILY: Professionals A Little About Us: ZAP is a full-service engineering, design, and construction...


  • Littleton, United States Cyfle Full time

    About the job Mechanical Engineering Supervisor Pay Rate: $135,000.00 We have partnered with an engineering and construction company in the Lakewood, CO area to provide them with a Mechanical Engineering Supervisor. Please review the below description and let us know if you are interested.Prioritized Must Have Skills for the Mechanical Engineering...


  • Littleton, United States Cyfle Full time

    About the job Mechanical Engineering Supervisor Pay Rate: $135,000.00 We have partnered with an engineering and construction company in the Lakewood, CO area to provide them with a Mechanical Engineering Supervisor. Please review the below description and let us know if you are interested.Prioritized Must Have Skills for the Mechanical Engineering...


  • Littleton, United States Terumo BCT Full time

    Requisition ID: 31831 At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our...

  • RAN Engineer

    3 weeks ago


    Littleton, United States US Tech Solutions Full time

    Position: RAN Engineer Location: Littleton, CO 80120 Duration: 03 Months Job Type: Contract to hire Job Description: • Work under the supervision of senior engineers, and help develop feature requirements for 5G radio. • Work on RAN test and validation processes, test cases, and testing of the RAN features and application in lab and field. •...

  • RAN Engineer

    1 week ago


    Littleton, United States US Tech Solutions Full time

    Position: RAN Engineer Location: Littleton, CO 80120 Duration: 03 Months Job Type: Contract to hire Job Description: • Work under the supervision of senior engineers, and help develop feature requirements for 5G radio. • Work on RAN test and validation processes, test cases, and testing of the RAN features and application in lab and field. •...

  • RAN Engineer

    1 month ago


    Littleton, United States GCB Services LLC Full time

    Responsibilities: Understand 3GPP specifications, perform analytical studies of the features, and evaluate their application and benefits for DISH wireless networks. Research and evaluate emerging technologies in the Wireless industry and translate their application in an operation environment and user experience. Work under the supervision of senior...


  • Littleton, United States The State of New Hampshire Full time

    **State of New Hampshire Job Posting** **Department of Health & Human Services** **Bureau of Family Assistance** **Littleton District Office **Family Services Specialist I-II** **Position #TMPPT1025** **29.5 hours per week** **Family Services Specialist I - $19.57-$25.89 USD** **Family Services Specialist II- $22.06-$29.43 USD** - See total...


  • Littleton, United States The State of New Hampshire Full time

    State of New Hampshire Job Posting Department of Health & Human Services Bureau of Family Assistance Littleton District Office Family Services Specialist I-II Multiple positions Available. **$19.57- **$29.43 per hour** - See total compensation information at the bottom of announcement. The State of New Hampshire, Bureau of Family Assistance has a Full...

  • RAN Engineer

    1 day ago


    Littleton, United States IT MINDS L.L.C. Full time

    Job DescriptionJob DescriptionRAN Engineer Littleton, CO(Onsite) Long Term Independent Visa and H1B Transfer Responsibilities: Understand 3GPP specifications, perform analytical studies of the features, and evaluate their application and benefits for DISH wireless networks. Research and evaluate emerging technologies in the Wireless industry and translate...

  • RAN Engineer

    2 weeks ago


    Littleton, United States Further Enterprise Solutions Full time

    Job Title: RAN Engineer Locations: Littleton, CO. Onsite is required Job Description: Responsibilities: •Understand 3GPP specifications, perform analytical studies of the features, and evaluate their application and benefits for wireless networks. •Research and evaluate emerging technologies in the Wireless industry and translate their application in an...


  • Littleton, United States UDR Full time

    Description UDR, Inc. is now hiring an IT Business Analyst II to join our team. Role is primarily remote but in-office (Highlands Ranch location), up to one time every other week. GENERAL SUMMARY OF DUTIES: Typical responsibilities include working with the business to elicit, analyze and document requirements for projects that encompass business process...