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Lead Validation Engineer

Company: Valpro
Location: California City
Posted on: September 18, 2022

Job Description:

Valpro has several available opportunities supporting our world-class client sites or partner organizations. Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below.


VALPRO is looking to identify top tier talent in the areas of automation and computer systems validation and system life cycle management. We are motivated to identify those that share our passion and can mirror the level of energy we put into ensuring that we remain on the cutting edge of the life sciences industry.

Due to project requirements expanding, we need to add a Lead Engineer to our team that have a proven track record in the SDLC (system development life cycle) of automated computer systems within biopharmaceutical environments. More specifically, we are looking for the following experience/capabilities:

  • Driving key deliverables to completion.
  • Possess process equipment knowledge and experience executing in the field under live conditions. Will require the ability to be able to run the equipment from an HMI (not a control room/remote desktop).
  • The success will lie in the Lead Validation Engineers' ability to functionally test the software on the equipment and troubleshoot the automation when test failures occur.
    This role supports the execution of projects. Supports the generation of quality assurance plans, verification plans, validation plans, and standard operating procedures as well as conduct risks assessments and participate in Quality/Regulatory audits. Develops and executes qualification protocols and final summary reports and may participate in commissioning activities.

    • 8+ years of Computer System Validation (CSV) experience with process control, SCADA and automation systems, MES and data integration systems (Emerson DeltaV, Rockwell Automation systems (Allen Bradley PLCs), Siemens Desigo EMS, and OSI PI experience is highly preferred)
      • Experience with automation, commissioning, qualification or operations in a cGMP environment of one (or more) of the following systems:
        • Autoclave
        • Parts Washer
        • Air Handling Units / HVAC
        • Media Preparation Tanks
        • Buffer Preparation Tanks
        • Ultrafiltraion / Diafiltration (UF/DF) Skids
        • Robotic Filling Machine
        • Chromatography Skids
        • Roller Bottle Carts
        • Utility systems (Chilled Water, Plant Air, Plant Steam, etc)
        • Direct experience developing validation protocols and execution of protocols.
        • Tactical thinker with experience working with customers developing testing, validation and/or quality strategies.
        • Excellent client communication skills.
        • Experience with the commissioning and qualification of automation and related systems within virtual and production cGMP environments.
        • Experience creating validation master plans and performing risk assessments.
        • Knowledge of current industry standards such as GAMP5 and ASTM E2500.
        • Passionate about leading and mentoring others.
        • Excellent client communication skills.

          Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives.

          Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

          Any third-party unsolicited resume submission(s) will immediately become the property of Valpro. Valpro will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

          Valpro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

Keywords: Valpro, Lancaster , Lead Validation Engineer, Engineering , California City, California

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