Talent.com
No longer accepting applications
Process Engineer II (238)

Process Engineer II (238)

Civica RxPetersburg, VA, United States
7 days ago
Job type
  • Full-time
Job description

About Civica :

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at   www.civicarx.org

Job Description

The Process Engineer II will play a critical role in bringing the Civica Petersburg, VA facility into a production-ready state, and in facility and equipment design through commercialization for a newly announced facility expansion for biologics. Scope for the expansion includes a dedicated high-speed cartridge filling line, substantial upgrade to critical utilities services, and dedicated formulation and processing suites with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities.

In the project delivery and startup phase of the project (currently in progress through 2025), the

Senior Process Engineer will be dynamic as we endeavor to support the startup, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

The Senior Process Engineer will act as a bridge between the project planning phase and ongoing operations by assuming System Owner responsibility for one or more manufacturing systems. In this role, the successful candidate will work closely with Validation, Manufacturing, and Quality Assurance to ensure availability, support, and maintenance of those system(s) throughout their lifecycle, and serve as subject matter expert internally and in regulatory inspections for production processes utilizing those systems.

Essential Duties and Responsibilities

  • You must have a willingness to perform "hands-on" work in a dynamic, team-oriented work setting.
  • Provide technical expertise on CQV activities and ensures compliance to regulatory requirements, industry best practices, and Engineering standards.
  • Participate directly in the Engineering process to develop and institute technical and procedural controls in the process design.
  • Accountable for CQV activity for assigned systems, including all phases : identifying user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
  • Execute Engineering deliverables in a timely manner, planning and proactively pursuing details and elevating risks appropriately to ensure project completion without avoidable delays.
  • Anticipate operational gaps (improvements to facility / equipment design, process inefficiencies, job hazards) rather than scrambling to fix issues in the project startup, leading to a smoother and safer transition to the Manufacturing team.
  • Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
  • Interpersonal skills to manage interactions and drive results across a range of business functions, education levels, and cultural backgrounds within the site. Extends to external communication with system vendors.

Basic Qualifications and Capabilities

  • Bachelor’s degree in Engineering required.
  • Strong mechanical aptitude.
  • Demonstrated ability to solve technical problems and implement projects.
  • Excellent interpersonal and communication skills, and fluency in English.
  • Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.
  • Interact well with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects with minimal required direction from his / her supervisor.
  • Willingness to adapt to changing priorities as project demands change.
  • Preferred

  • 5+ years of experience in sterile injectables, drug-device combination products, or biologics.
  • SME-level knowledge of drug product processing equipment (e.g. single-use mixers and stainless steel formulation vessels, parts washers, autoclaves, component processors, aseptic filling equipment – vials, pre-filled syringes, and cartridges – isolators with VPHP decontamination, filter integrity and isolator glove integrity testers).
  • Direct experience ordering capital equipment, materials required for production, spare parts, and calibration and maintenance services.
  • Familiarity with cleaning validation and / or process validation.
  • Previous work at greenfield sites or substantial facility expansion projects.
  • Create a job alert for this search

    Engineer Ii • Petersburg, VA, United States

    Related jobs
    • Promoted
    Process Engineer II (238)

    Process Engineer II (238)

    Civica RxPetersburg, VA, US
    Full-time
    Critical shortages of essential generic injectable drugs are an ongoing crisis in U.Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.Sh...Show moreLast updated: 17 days ago
    • Promoted
    Industrial Engineer

    Industrial Engineer

    VirtualVocationsRichmond, Virginia, United States
    Full-time
    A company is looking for an Industrial Engineer to optimize manufacturing processes and improve efficiency.Key Responsibilities Drive continuous improvement projects Capture cost savings and per...Show moreLast updated: 30+ days ago
    • Promoted
    Process Engineer II

    Process Engineer II

    Global Recruiters of Dublin (GRN Dublin)Richmond, VA, US
    Full-time
    We are searching for a Process Engineer with experience in pharmaceutical drug product manufacturing, specifically in the areas of sterile injectable product formulation and filling, barrier system...Show moreLast updated: 30+ days ago
    • Promoted
    Process Engineer II (Richmond)

    Process Engineer II (Richmond)

    Global Recruiters of Dublin (GRN Dublin)Richmond, VA, US
    Part-time
    We are searching for a Process Engineer with experience in pharmaceutical drug product manufacturing, specifically in the areas of sterile injectable product formulation and filling, barrier system...Show moreLast updated: 6 days ago
    • Promoted
    Packaging Process Engineer II (239)

    Packaging Process Engineer II (239)

    Civica RxPetersburg, VA, US
    Full-time
    Critical shortages of essential generic injectable drugs are an ongoing crisis in U.Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.Sh...Show moreLast updated: 30+ days ago
    • Promoted
    Hybrid Service Writer / Diesel Mechanic

    Hybrid Service Writer / Diesel Mechanic

    TruckPro LLCQuinton, VA, US
    Full-time
    Hybrid Service Writer / Diesel Mechanic.This dual-role position requires a professional who can effectively manage customer expectations while expertly diagnosing, maintaining, and repairing diesel...Show moreLast updated: 4 days ago
    • Promoted
    Marine Assistant Engineer

    Marine Assistant Engineer

    PEMCCOSurry, VA, US
    Full-time
    Information Technology and Information Management (IT / IM) services firm.We assist our customers in maximizing existing and emerging technologies to achieve their desired business productivity objec...Show moreLast updated: 30+ days ago
    • Promoted
    Mechanical Engineer III

    Mechanical Engineer III

    MWResource, Inc.Richmond, VA, US
    Full-time
    Hybrid : 9 / 80 - Every Other Friday Off.Duration : 12 months – Possible Extension.Day-to-day duties would be to serve as an engineer on the main condenser replacement project.Duties include, but...Show moreLast updated: 21 days ago
    • Promoted
    Engineer I / Engineer II

    Engineer I / Engineer II

    BHE GT&SGlen Allen, Virginia, US
    Full-time
    Is this the role you are looking for If so read on for more details, and make sure to apply today.BHE GT&S has an exciting opportunity as an Engineer I or Engineer II at our Headquarters in Gle...Show moreLast updated: 25 days ago
    • Promoted
    Principal Engineer : Utilities and HVAC

    Principal Engineer : Utilities and HVAC

    Civica RxPetersburg, VA, US
    Full-time
    Critical shortages of essential generic injectable drugs are an ongoing crisis in U.Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.Sh...Show moreLast updated: 30+ days ago
    • Promoted
    Warehouse Associate

    Warehouse Associate

    AutoZoneProvidence Forge, VA, US
    Full-time
    Are you a strong communicator, adaptable leader, and team player looking for a fast-paced, hands-on role in warehouse operations? AutoZone is hiring Warehouse Associates to support order fulfillmen...Show moreLast updated: 25 days ago
    • Promoted
    Senior Quality Engineer - Data Integrity (388)

    Senior Quality Engineer - Data Integrity (388)

    Civica RxPetersburg, VA, US
    Full-time
    Critical shortages of essential generic injectable drugs are an ongoing crisis in U.Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.Sh...Show moreLast updated: 13 days ago
    • Promoted
    Quality Systems Leader

    Quality Systems Leader

    CelaneseRichmond, VA, US
    Full-time
    Dupont Site Road, Richmond, VA 23234.The Quality Systems Leader is responsible for ensuring the implementation, maintenance, and continuous improvement of an effective Quality Management System (QM...Show moreLast updated: 30+ days ago
    • Promoted
    Validation Engineer II (511)

    Validation Engineer II (511)

    Civica RxPetersburg, VA, US
    Full-time
    Critical shortages of essential generic injectable drugs are an ongoing crisis in U.Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.Sh...Show moreLast updated: 3 days ago
    • Promoted
    Controls Engineer

    Controls Engineer

    CondairChester, VA, US
    Full-time
    Group, founded in 1948 and based in Switzerland is the global leader in humidification, dehumidification and evaporative cooling. Supported by science, we engineer individual, holistic solutions tha...Show moreLast updated: 16 days ago
    • Promoted
    Project Manager - Site Establishment

    Project Manager - Site Establishment

    KongsbergBarhamsville, VA, US
    Permanent
    Kongsberg Defense & Aerospace, Inc.Norway's premier supplier of defense products and systems for command and control, surveillance, space, tactical communications, remote weapon stations an...Show moreLast updated: 13 days ago
    • Promoted
    Engineer I / Engineer II

    Engineer I / Engineer II

    BHE GT&S CareersGlen Allen, Virginia, US
    Full-time
    BHE GT&S has an exciting opportunity as an Engineer I or Engineer II at our Headquarters in Glen Allen, VA.Spill Prevention Control and Countermeasures (SPCC) Plan coordinator for facilities throug...Show moreLast updated: 25 days ago
    • Promoted
    Packaging Process Engineer II (964)

    Packaging Process Engineer II (964)

    Civica RxPetersburg, VA, US
    Full-time
    Critical shortages of essential generic injectable drugs are an ongoing crisis in U.Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.Sh...Show moreLast updated: 17 days ago
    • Promoted
    • New!
    Engineer I / Engineer II

    Engineer I / Engineer II

    BHE GTandSGlen Allen, VA, United States
    Full-time
    BHE GT&S has an exciting opportunity as an Engineer I or Engineer II at our Headquarters in Glen Allen, VA.Spill Prevention Control and Countermeasures (SPCC) Plan coordinator for facilities throug...Show moreLast updated: 8 hours ago
    Engineer, Principal (Process Engineer)

    Engineer, Principal (Process Engineer)

    Vets HiredRichmond, Virginia, United States
    Full-time
    Quick Apply
    Two openings are available for Principal Engineersone focused on Water and one on Wastewater operations.Reporting to senior leadership and working closely with plant superintendents, maintenance, a...Show moreLast updated: 17 days ago