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5465- CQV Engineer / Validation Engineer

Los Angeles, CA

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

CQV Engineer Responsibilities:

Two year project at our client site in Los Angeles, CA for an individual with Facilites CQV experience including EMPO, Vessel IOV and IOPQ, including mixing and temp mapping experience.

  • General Project Support
    • Attend Weekly Project Meetings
    • Attend Daily Construction Meetings
    • Attend Monthly EH&S Safety Meetings
  • Generation and Modification of project lifecycle documentation for the LA Plant site
    • User Requirements Specifications
    • Functional Specifications
    • Design Specifications
    • SOPs
    • Management of Change (MOC)
    • FMEA
    • HAZOPs
    • Risk Assessments
    • Gap Assessments
    • Project Closeout Documentation
    • Turnover Package Generation
    • Project Change Requests
  • Manage Installation and Operational Commissioning
    • Author and Approve
    • Execution
    • Function Testing
    • BOM Updates
    • PM Generation
    • Asset Lifecycle
    • Drawing Updates
    • Support site acceptance testing to review system documents and functions during SAT
    • Summary Report
  • Manage Installation, Operational, and Performance Qualification
    • Author and approve
    • Develop and execute qualification protocols
    • Assist with any deviation resolution and handling
    • Execution
      •  

  • VALIDATION SUPPORT - Responsibilities include (but are not limited) to the following:

    Installation Qualification

    o      Equipment installation verification and confirmation that equipment is installed in

    Accordance with manufacturer's specifications.

    o      Document equipment installation and location.

    Operational Qualification

    • Equipment functional verifications under operational conditions.
    • Conduct testing of equipment functionality and performance.
    • Documenting of all test results and deviations

    Performance Qualification

    • Confirmation of the fractionation performance
    • Validate the manufacturing process and critical process parameters.
    • Generate and review batch records and documentation.

    Process Validation

    • Conduct process validation studies to ensure consistent product quality.
    • Perform risk assessments and implement process controls.
    • Develop and validate analytical methods for product testing.

    Cleaning Validation

    o   Validate the cleaning procedures for the equipment to prevent cross contamination.

    o   Document cleaning validation protocols and results

    Facility Qualification

    o   Conduct validation of critical facility systems

    Software Validation

    o   Validate any software system used in the fractionation process, including data management and process control systems.

    Validation Reports

    • Compile validation reports summarizing all activities, results, and conclusions.
    • Include recommendations for ongoing monitoring and maintenance

 

Requirements:

  • 1-4 years of CQV Validation experience in GxP environments
  • Onsite work requirements M-F in Los Angeles, CA for up to 2 years
  • Specific documented experience with Facilities CQV activities, including EMPO, Vessel IOV and IOPQ, including mixing and temperature mapping
  • Additional experience in Utilities CQV work (WFI, Alcohol, N2, Compressed Air, etc), CIP, Filter Press, Centrifuge and Cleaning Validation is ideal
  • The job also requires daily job walks of the construction site daily in full PPE                                             

 

 

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$59,951 - $103,860 USD

Benefits

Why Choose Verista?

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

For more information about our company, please visit us at Verista.com

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