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Validation Engineer III

Company: Catalent
Location: Greenville
Posted on: March 17, 2023

Job Description:

Validation Engineer III

Position Summary

The Validation Engineer III provides direct validation support to pharmaceutical development and manufacturing operations. Under minimum supervision, the Validation Engineer III performs quality functions to ensure accurate execution and documentation of all activities and projects as assigned

The Role

  • Author/Review process validation protocols and validation summary reports
  • Perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification
  • Follow the site master validation program
  • Follow and enforce the validation life cycle approach for site
  • Proficient knowledge of Validation Principles, Validation Sampling, and OSD Manufacturing Processes/Equipment/Facilities
  • Review and approve technical documents of peers independently (protocols/reports/SOPs, risk assessments, etc.)
  • Create and maintain a climate of quality and safety within the team and other departments, by identifying and monitoring quality and safety standards
  • Other duties as assigned

    The Candidate
    • Bachelor's degree in a Technical or Life Sciences discipline with at least 5 years of experience in pharmaceutical industry
    • Associate degree in a Technical or Life Sciences discipline with at least 7 years of experience in pharmaceutical industry
    • At least 3 years validation experience
    • 2 years recent experience in one or more of the following areas: process validation, equipment validation, CFR 210 Part 11 software validation or cleaning validation with at least one-year experience preparing and implementing process validation protocols and authoring validation summary reports

      Why You Should Join Catalent

      • Several Employee Resource Groups focusing on D&I
      • Employee Stock Purchase Program
      • Tuition Reimbursement- Let us help you finish your degree or earn a new one!

        • Generous 401K match
        • 19 days accrued PTO + 8 paid holidays

          Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

          Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

          personal initiative. dynamic pace. meaningful work.

          Visit Catalent Careers to explore career opportunities.

          Catalent is an Equal Opportunity Employer, including disability and veterans.

          If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

          Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

          Important Security Notice to U.S. Job Seekers:

          Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

Keywords: Catalent, Greenville , Validation Engineer III, Engineering , Greenville, North Carolina

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