Jobs
>
Chicago

    Validation Engineer - North Chicago, United States - AbbVie

    AbbVie
    AbbVie North Chicago, United States

    2 days ago

    Default job background
    Full time
    Description

    Company Description

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us Follow @abbvie onX,Facebook,Instagram,YouTubeandLinkedIn.
    Job Description

    Key Responsibilities

  • Responsible for creation, planning & approval of validation documents to support validation requirements.
  • Responsible for participating in implementation & maintenance of effectiveness of the Quality system to meet applicable regulatory requirements.
  • Adhere to Good Manufacturing Practices (GMPs), ISO:13485, ISO:14971, & 21 CFR 820.
  • Ensure that practices & procedures comply with company policies & applicable regulations for the Quality areas.
  • Execute tasks as required to implement Validation Master Plan & maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing process to demonstrate that products will perform consistently as intended.
  • Supervise contract validation resources in the timely completion of activities in his/her area of responsibility.
  • Represent department in quality audits, both internal and external, regarding validation & engineering compliance.
  • Perform Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ).
  • Participate in implementation & maintenance of effectiveness of Quality System to meet all applicable regulatory requirements.
  • Ensure that all practices & procedures comply with company policies & applicable regulations for the Quality areas.
  • Document control of nonconforming products & implementation of corrective & preventative actions (CAPA) to address identified root causes compliant with ISO:13485 standards & 21 CFR
  • Execute process monitoring plans based on quantifiable production & quality metrics.
  • Participate with plant & external engineering resources on new installations & systems to ensure that factory, site, & commissioning documentation is in accordance with current Good Manufacturing Practices (cGMP) & supports validation.
    Qualifications
    Must possess a Bachelors degree or foreign academic equivalent in Biology, Chemistry, Biomedical Engineering, Mechanical Engineering or related scientific or engineering field plus an academic or industrial background in:
    1. Good Manufacturing Practices (GMPs), ISO:13485, ISO:14971, & 21 CFR 820;
    2. Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ);
    3. documenting control of nonconforming products & implementation of corrective & preventative actions (CAPA) to address identified root causes compliant with ISO:13485 standards & 21 CFR 820.90; &
    4. executing process monitoring plans based on quantifiable production & quality metrics. Apply online at Refer to Req ID: REF23813S.


      Additional Information

      We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.

      AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

  • PSC Biotech Corporation

    Validation Engineer

    3 weeks ago

    PSC Biotech Corporation Chicago, United States Full time

    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 ...

  • Sterling Engineering Inc.

    Validation Engineer

    2 weeks ago

    Sterling Engineering Inc. North Chicago, United States

    Job Description · Job DescriptionJob Overview: · The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and u ...

  • AbbVie

    Validation Engineer

    2 weeks ago

    AbbVie North Chicago, United States

    Job Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...

  • Katalyst Healthcares and Life Sciences

    Validation Engineer

    3 weeks ago

    Katalyst Healthcares and Life Sciences Chicago, United States

    Responsibilities: Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols (first in kind) and Validation/Qualification Policies. · Initiate an own Change Controls; provide validation assessments and remediation plans as required by the system/equipmen ...

  • PSC Biotech

    Validation Engineer

    1 week ago

    PSC Biotech Chicago, United States

    Job Description · 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 i ...

  • PSC Biotech

    Validation Engineer

    2 weeks ago

    PSC Biotech Chicago, 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 ...

  • Colsh Consultants LLC.

    Validation Engineer

    4 weeks ago

    Colsh Consultants LLC. Chicago, United States

    StrongExperience in Computer Systems Validation (CSV) within the Pharmaceuticalindustry. · • Required Bachelor's degree in pharmaceutical Science OR related field of study. · •Schedule and plan equipment and process qualification workload to meet approvedschedules. · •Handle mult ...

  • Ingredion

    Pharmaceutical Validation Engineer

    3 days ago

    Ingredion Chicago, United States

    This position is responsible for development, execution, & analysis of validation projects to demonstrate facility, equipment, and process consistency and cGMP compliance for an API facility. Responsibilities include the generation and execution of I Validation Engineer, Pharmace ...

  • Saxon Global

    Model Validation Engineer

    1 week ago

    Saxon Global Chicago, United States

    Client: One of the predominant US financial regulatory institutions · Title: Model Validation Engineer · Location: Hybrid Onsite (Chicago IL) 3 days/week Mandatory · Contract: 12 months · Target Rate: 85/hr C2C · Visa Status: USC, GC, H4 · Summary of 'Must Have' Skills: · ...

  • MMR Consulting

    PHARMACEUTICAL - Lead CQV / Validation Engineer

    2 weeks ago

    MMR Consulting Chicago, United States

    Job Description · Job DescriptionSalary: · Previous Pharmaceutical/Biotech experience is mandatory for this role. · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in North America and globally. Its services i ...

  • Jabil Circuit, Inc.

    Lead Product Validation Engineer

    2 weeks ago

    Jabil Circuit, Inc. Chicago, United States

    Job Description · As a Lead, you own project validation will be able to technically lead the entire cross functional design team on their interactions and responsibilities for that project. A Lead Engineer is responsible for ensuring the phase gate technical milestones are met, i ...

  • Mallinckrodt Pharmaceuticals

    Sr. Validation Engineer

    2 weeks ago

    Mallinckrodt Pharmaceuticals Hobart, United States Full time

    Description · Summary of Position · Implements and executes validation projects including Equipment Validation, Packaging Validation, Computer System Validation, Data Integrity Assessments, and Cleaning Validation. Coordinates with cross-functional resources in the execution of ...

  • MMR Consulting Inc

    PHARMACEUTICAL - Lead CQV / Validation Engineer

    3 weeks ago

    MMR Consulting Inc Chicago, United States

    Job Description · Job Description Salary: · Previous · Pharmaceutical/Biotech · experience is mandatory for this role. · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in North America and globally. Its se ...

  • Fresenius Kabi USA, LLC

    sr validation engineer

    4 weeks ago

    Fresenius Kabi USA, LLC Melrose Park, United States

    Job Summary Responsible for providing technical support to operations in terms of initial equipment/facility/utility qualifications and equipment/facility/utility requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance a ...

  • Fresenius Kabi

    sr validation engineer

    4 weeks ago

    Fresenius Kabi Melrose Park, United States

    Job Summary · Responsible for providing technical support to operations in terms of initial · equipment/facility/utility · qualifications and · equipment/facility/utility · requalifications. Will participate in process and equipment improvement teams charged with enhancing t ...

  • Sterling Engineering

    Validation Engineer

    4 weeks ago

    Sterling Engineering Westchester, United States

    Job Description · Job Overview: · The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old do ...

  • Sterling Engineering

    Validation Engineer

    2 weeks ago

    Sterling Engineering Westchester, United States

    Job Overview: · The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old documentation to new ...

  • Randstad

    sr validation engineer

    6 days ago

    Randstad Morton Grove, United States

    sr validation engineer. · morton grove , illinois · posted 7 days ago · job details · summary · $80,000 - $100,000 per year · permanent · bachelor degree · category life, physical, and social science occupations architecture and engineering occupations · reference48177 · j ...

  • Randstad

    sr validation engineer

    1 week ago

    Randstad Morton Grove, United States

    sr validation engineer. · morton grove , illinois · posted 4 days ago · job details · summary · $80,000 - $100,000 per year · permanent · bachelor degree · category life, physical, and social science occupations architecture and engineering occupations · reference48177 · j ...

  • Randstad

    sr validation engineer

    1 week ago

    Randstad Morton Grove, United States

    sr validation engineer. · morton grove , illinois · posted 5 days ago · job details · summary · $80,000 - $100,000 per year · permanent · bachelor degree · category life, physical, and social science occupations architecture and engineering occupations · reference48177 · j ...