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Manager Validation & Engineering

Company: Charles River Laboratories
Location: Rockville
Posted on: January 16, 2022

Job Description:

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.

IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.Job Summary
The Manager, Engineering & Validation supports site projects and ongoing validation. Primarily responsible for the design, authorship, and execution of commissioning, qualification and/or validation studies.
Duties and Responsibilities

  • Manages a variety of complex issues in associated projects, plans and schedules project implementation. Responsible for defining scope of work for functional team/contractors.
  • Reviews and approves complex design concepts and analysis of technologies that incorporate own area of expertise as well as multiple disciplines, as applicable.
  • Reviews and analyzes proposals to determine if benefits derived and possible applications justify expenditures. Responsible for preparation of project cost estimates. Monitors all project expenditures and cost tracking.
  • Provides leadership to assess and provide guidance and risk assessments regarding validation and compliance requirements in own area of expertise.
  • Assist and guides the strategy and requirements of how validation is to be accomplished.
  • Approves protocols and support documentation.
  • Prepares regulatory submissions and presents validation dossiers to regulatory authorities during routine internal and regulatory inspections.
  • Supports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
  • Leads projects with complex features.
  • Other responsibilities as needed.
    Job Qualifications
    Qualifications for the Job
    • Bachelor's degree in science, engineering, or another related technical field.
    • A minimum of 3 years of relevant experience in a GMP regulated environment.
    • At least 3 years of commissioning, qualification, and validation (CQV) required.
    • At least 2 years of professional supervision experience preferred.
    • At least 2 years of project management experience highly desired.
    • Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
    • Validation and/or system experience.
    • Ability to effectively coordinate contractors.
    • Ability to influence outside of immediate scope of responsibility.
    • Direct experience with manufacturing operations and biotechnology processes required.
    • Strong organizational skills, excellent writing, and communication skills.
    • Proficiency with Microsoft Office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.
    • Must be self-motivated, capable of analyzing and solving complex problems through innovative thought and experience.
    • Has demonstrated effective leadership and supervisory skills.IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.

      Vaccine Mandate
      Charles River is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021. Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees.

      Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition ( so that information can be provided about the accommodation process at Charles River.
      About Biologics Testing Solutions
      With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

Keywords: Charles River Laboratories, Rockville , Manager Validation & Engineering, Executive , Rockville, Maryland

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