Validation Engineer

3 weeks ago


Portsmouth, United States Trinity Consultants Full time

Validation Engineer

Location: Portsmouth, NH

Join ADVENT Engineering, a leading engineering and consulting firm dedicated to the pharmaceutical and biotechnology sectors. With our headquarters near San Francisco and operations throughout the Eastern and Western US, Canada, and Singapore, we are positioned at the forefront of global pharmaceutical and biotechnology facility design, process engineering, and quality system projects.

At ADVENT, we specialize in process engineering, automation engineering, project engineering, facility design, start-up and commissioning, as well as validation and compliance consulting for prominent biotechnology and pharmaceutical manufacturing companies.

As a key member of our engineering team, you will collaborate with experts in the field to design, automate, commission, and start various processes, systems, and facilities. We are looking for candidates with a blend of strong technical aptitude, automation engineering skills, and proficiency in technical writing.

Responsibilities:

  • Develop and implement Quality System documentation to ensure effective validation practices within the organization.
  • Create user requirement specifications (URS), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols, executing them in alignment with Good Documentation Practices (GDP) and internal quality standards.
  • Design comprehensive validation strategies backed by suitable statistical analyses; perform and coordinate validation activities, review and compile results, and draft validation reports.
  • Conduct Data Integrity Assessments and evaluate systems for compliance with 21 CFR Part 11 regulations.
  • Collaborate on user and functional requirements for current and upcoming processing equipment, drafting necessary documentation and interfacing with manufacturers to ensure compliance.
  • Support cross-functional teams, including R&D and Manufacturing, to facilitate successful technology transfer and continuous improvement initiatives.
  • Manage assigned tasks efficiently, proactively communicating any delays or issues to the validation manager and relevant stakeholders.
  • Review DeltaV software and specifications to design robust test protocols.
  • Adhere strictly to all regulatory, corporate, and Quality System policies.

Qualifications:

  • B.S. / M.S. in engineering or related field.
  • A minimum of 4+ years of experience in an FDA-regulated environment; experience with upstream and downstream equipment is a plus.
  • At least 2 years of experience with DeltaV, including software interaction and protocol design for customizations.
  • Expertise in Design Documentation (URS, FRS, DS, etc.), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), and Quality Systems (Change Control, Non-Conformances, Requalification, etc.).
  • Strong understanding of the Computer Systems Validation lifecycle and documentation practices.
  • Proficient in Microsoft Word, Excel, and PowerPoint.
  • Ability to work independently and manage multiple projects simultaneously with minimal supervision.
  • Excellent communication, interpersonal, and teamwork skills are essential.
  • Strong technical writing and presentation abilities are required.

**Please note, we are not able to work with any 3rd party vendors or C2C.**



  • Portsmouth, New Hampshire, United States Lonza America Inc Full time

    Are you passionate about quality engineering and looking for a challenging opportunity? Do you want to make a meaningful difference in the world?Job DescriptionWe are seeking an experienced Validation and Compliance Expert to join our team. As a key member of our quality engineering department, you will be responsible for ensuring the detailed execution of...


  • Portsmouth, New Hampshire, United States Lonza America Inc Full time

    Lonza America Inc is a global leader in life sciences operating across five continents. We work in science, devising ideas that help businesses to help people.Job OverviewOur company culture is built on respect, trust, and open communication. We believe that every individual has the potential to make a meaningful difference in the world.As a Quality...


  • Portsmouth, United States Lonza Full time

    Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely...


  • Portsmouth, NH, United States Lonza Full time

    Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely...

  • CSV/DeltaV Engineer

    3 weeks ago


    Portsmouth, United States Trinity Consultants - Advent Engineering Full time

    CSV/DeltaV Engineer Location:Portsmouth, NHADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global...

  • CSV/DeltaV Engineer

    3 weeks ago


    Portsmouth, United States Trinity Consultants - Advent Engineering Full time

    CSV/DeltaV EngineerLocation: Portsmouth, NHADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global...

  • Project Engineer

    4 weeks ago


    Portsmouth, United States COMMONWEALTH OF VIRGINIA DBA VIRGINIA PORT A Full time

    The Opportunity: Project Engineer (Civil) The Port of Virginia – Virginia International Terminals is seeking a Project Engineer with expertise in Civil Engineering and/or Construction Project Management to provide engineering expertise in the planning, design, construction and maintenance of the Commonwealth-operated marine and intermodal terminal...

  • Software Engineer

    3 days ago


    Portsmouth, United States Vatn Systems Full time

    Position Overview:At Vatn Systems, we are at the forefront of underwater technology, developing innovative autonomous underwater vehicles that push the boundaries of technology. We are looking for a Software Engineer with strong proficiency in C++, Python, ROS (Robot Operating System), and Linux to join our team. In this role, you will spearhead the...

  • CSV/DeltaV Engineer

    2 days ago


    Portsmouth, NH, United States Trinity Consultants - Advent Engineering Full time

    CSV/DeltaV Engineer Location: Portsmouth, NH ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global...

  • Quality Engineer

    3 weeks ago


    Portsmouth, United States Alexander Technology Group Full time

    The Alexander Technology Group is looking for a Quality Engineer with expertise in medical products. The ideal candidate will ensure compliance with regulatory standards and drive continuous improvement in product quality and safety.This is a fully on-site positionFull-time/permNO 3rd party c2c applicants will be consideredKey Responsibilities:Quality...

  • Project Engineer

    1 week ago


    Portsmouth, United States COMMONWEALTH OF VIRGINIA DBA VIRGINIA PORT A Full time

    The Opportunity: Project Engineer (Civil) The Port of Virginia Virginia International Terminals is seeking a Project Engineer with expertise in Civil Engineering and/or Construction Project Management to provide engineering expertise in the planning, design, construction and maintenance of the Commonwealth-operated marine and intermodal terminal facilities....

  • Project Engineer

    3 weeks ago


    Portsmouth, United States COMMONWEALTH OF VIRGINIA DBA VIRGINIA PORT A Full time

    The Opportunity: Project Engineer (Civil) The Port of Virginia – Virginia International Terminals is seeking a Project Engineer with expertise in Civil Engineering and/or Construction Project Management to provide engineering expertise in the planning, design, construction and maintenance of the Commonwealth-operated marine and intermodal terminal...

  • Project Engineer

    3 weeks ago


    Portsmouth, United States COMMONWEALTH OF VIRGINIA DBA VIRGINIA PORT A Full time

    The Opportunity: Project Engineer (Civil) The Port of Virginia – Virginia International Terminals is seeking a Project Engineer with expertise in Civil Engineering and/or Construction Project Management to provide engineering expertise in the planning, design, construction and maintenance of the Commonwealth-operated marine and intermodal terminal...

  • Project Engineer

    2 weeks ago


    Portsmouth, United States COMMONWEALTH OF VIRGINIA DBA VIRGINIA PORT A Full time

    The Opportunity: Project Engineer (Civil) The Port of Virginia – Virginia International Terminals is seeking a Project Engineer with expertise in Civil Engineering and/or Construction Project Management to provide engineering expertise in the planning, design, construction and maintenance of the Commonwealth-operated marine and intermodal terminal...

  • Platform Engineer

    4 weeks ago


    Portsmouth, United States ManTech Full time

    Currently, ManTech is seeking a motivated, career and customer-oriented Platform Engineer to join our team at SURFMEPP in Portsmouth, VA.Job Summary:The Surface Maintenance Engineering, Planning, Program (SURFMEPP) maintains, monitors, and refines Class-wide and Individual-Ship Maintenance Plans for all non-nuclear surface ships to ensure material readiness...

  • Platform Engineer

    4 weeks ago


    Portsmouth, United States ManTech Full time

    ManTech is seeking a motivated, career and customer-oriented Platform Engineer to join our team at SURFMEPP in Portsmouth, VA.Job Summary:The Surface Maintenance Engineering, Planning, Program (SURFMEPP) maintains, monitors, and refines Class-wide and Individual-Ship Maintenance Plans for all non-nuclear surface ships to ensure material readiness for the...

  • Ferry Chief Engineer

    4 weeks ago


    Portsmouth, United States Virginia Department of Transportation Full time

    Title: Ferry Chief EngineerState Role Title: Watercraft Operations Manager IHiring Range: $71,414 to $116,048Pay Band: 4Agency: VA Dept of TransportationLocation: Jamestown Scotland FerryAgency Website: www.virginiadot.org/jobsRecruitment Type: General Public - GJob Duties***This position is eligible to receive a sign on bonus of up to $10,000 based on the...


  • Portsmouth, United States Naval Facilities Engineering Systems Command (NAVFAC) Full time

    Open to all US Citizen Title/Series /Grade: Engineer / Architect- GS-08XX-13 Pay Range: $99,714 - $129,625 per year Work Schedule: Full-Time Appointment Type: Permanent Service: Competitive Location: Naval Shipyard, Portsmouth, VA Duties: You will provide assistance and technical guidance to other engineers/architects, or other NAVFAC business/support...


  • Portsmouth, United States Naval Facilities Engineering Systems Command (NAVFAC) Full time

    Open to all US CitizenTitle/Series /Grade: Engineer / Architect- GS-08XX-13Pay Range: $99,714 - $129,625 per yearWork Schedule: Full-TimeAppointment Type: PermanentService: CompetitiveLocation: Naval Shipyard, Portsmouth, VADuties: You will provide assistance and technical guidance to other engineers/architects, or other NAVFAC business/support lines or...


  • Portsmouth, United States Naval Facilities Engineering Systems Command (NAVFAC) Full time

    Open to all US CitizenTitle/Series /Grade: Engineer / Architect- GS-08XX-13Pay Range: $99,714 - $129,625 per yearWork Schedule: Full-TimeAppointment Type: PermanentService: CompetitiveLocation: Naval Shipyard, Portsmouth, VADuties:You will provide assistance and technical guidance to other engineers/architects, or other NAVFAC business/support lines or...