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Senior Validation Engineer

Company: Verista
Location: Baton Rouge
Posted on: August 7, 2022

Job Description:

DescriptionLooking for an exciting opportunity at a fast growing, employee-oriented company? Verista's 500+ experts team up with the world's most recognizable brands in the life science industry to solve their business needs. Whether it's compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.Verista's experts include SMEs across the spectrum of pharma, medical devices and biotech industries. As a result, we're uniquely capable of offering transformative, integrated solutions, new perspectives, and consistent results.Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable our clients to improve the quality of patient healthcare worldwide. Our talented and dedicated professionals are committed to making an impact every day.We deliver solutions that are right the first time.Typical Responsibilities of a Senior Validation Engineer:

  • Assesses client computer systems and identify any potential Part 11 or Annex 11 gaps to ensure data integrity best practices are enforced.
  • Review off-the-shelf software, software development tools and software systems used in quality processes to determine appropriate validation requirements.
  • Provide routine progress and issue update to project team.
  • Execute Commissioning, Installation, Operation and Performance Qualification Protocols for various life science lab, computer system, analytical instruments and manufacturing equipment and utilities.
  • Generate/Revise/Execute system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
  • Ensuring that project deliverables are compliant with all applicable regulations including FDA's GLP, GCP and GMP/Part 11 and EU Annex 11 and industry guidelines like ISPE GAMP5.
  • Prepare and execute SAP qualification. Requirements
    • You've earned your BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.
    • You've gained 2-10 years relevant industry experience working in a cGMP environment.
    • You've got working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, pharmaceuticals, and medical devices in your toolbox.
    • You've collected previous experience in writing and executing Validation protocols such as Installation, Operation and Performance Qualification documents.
    • Experience with SAP, LIMS and Trackwise. BenefitsBecause employees are the key to our success, Verista offers strong benefits and incentives including:
      • Health, Dental, and Vision Insurance
      • 401(k) Retirement Plan with a company match
      • Paid Time Off Pay
      • Tuition Reimbursement
      • 9 Company Paid Holidays
      • Paid Long Term & Short Term Disability Insurance
      • Training and Development
      • Paid Maternity Leave and Parental Leave
      • Travel Bonus
      • Employee Referral Program
      • Tuition Reimbursement
      • Marriage Leave
      • Bereavement
      • Verista is an Equal Opportunity Employer

Keywords: Verista, Baton Rouge , Senior Validation Engineer, Engineering , Baton Rouge, Louisiana

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