Validation Engineer III, Equipment & CSV - Greenville North Carolina

Company: Disability Solutions
Location: Greenville, North Carolina
Posted On: 04/15/2024

Validation Engineer III, Equipment & CSVCatalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.The PositionThe Validation Engineer III, Equipment & CSV will provide direct validation support to pharmaceutical development and manufacturing operations. Under little to no supervision the Validation Engineer III, Equipment & CSV will perform quality functions to ensure accurate execution and documentation of all activities and projects as assigned. The Role

• Author/Review executed equipment qualification protocols and summary reports.
• Approve technical engineering and facility documents.
• 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.
• Oversight and administration of site master validation program.
• Update and maintain site validation master plan to align with company and industry regulations.
• Lead validation projects in various disciplines, develop strategy and timelines to deliver according to department and site objective and goals.-- Work with project teams to meet project milestones and deliverables to achieve OTD and RFT metrics.
• Assist in the implementation for improved site validation activities and the quality systems related to these activities.
• All other duties as assigned.The Candidate
  • Bachelor's degree in a Technical or Life Sciences discipline with at least 10 years of experience in the pharmaceutical industry and at least 6 years in validation.
  • Associate degree in a Technical or Life Sciences discipline with at least 12 years of experience in the pharmaceutical industry and at least 8 years in validation.
  • In lieu of Technical/Life Sciences degree, a Bachelor's degree with at least 8 years of experience in the pharmaceutical industry and at least 4 years in the areas of Equipment/Facilities and Computer Validation may be substituted.
  • 4 years of recent experience in one or more of the following areas: process validation, equipment validation, CFR 210 Part 11 software validation or cleaning validation - At least 3 years of experience preparing and implementing validation protocols and authoring validation summary reports.
  • This position requires you to wear a respirator for your safety, and as such, employment is contingent upon you being able to complete a medical evaluation with satisfactory results prior to the start of your employment.
  • Some exposure to hazardous chemicals and other active chemical ingredients.
  • Position requires the capacity to handle and manipulate objects using hands and arms.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 holidaysCatalent 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 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 spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice . More...

          

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