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Validation Engineer (2809716002)
Catalent are currently recruiting for a Validation Engineer to join the Nottingham site. The Validation Engineer will manage the delivery and support of validation for new and existing GMP equipment, facilities and processes. Ensuring GMP compliance for all manufacturing facilities, equipment and processes in line with regulatory expectations and local documentation. The role: Performing validation on new and legacy assets in accordance with agreed plans and timelines to ensure maximum availability of Catalent assets. Ensuring periodic review and periodic requalification are carried out in a timely manner. Ensure validation lifecycle documents are maintained and audit ready. Ensure all validation activities are completed against regulatory expectations and local documentation. Manage expectations of key stakeholders through proactive communication of issues, concerns and remediation activities. Understanding of the requirements for PPQ and CPV, a knowledge of statistical analysis and systems to support. effectively present information and respond to questions from peers, management, suppliers and customers Understanding of Risk Based Validation Approach according to current regulatory expectations Knowledge or awareness of Annex 15, 11, GAMP and other relevant industry standards The candidate: Knowledge of statistical system such as MiniTab, or similar, to support PPQ and CPV (Highly desirable) Experience in Commercialization (advantageous) GMP experience Formal qualification in a scientific or engineering subject or a minimum of 3 years’ experience of performing validation tasks Strong organizational skills Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access) Ability to work effectively under pressure to meet deadlines 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 and does not discriminate based on any characteristic protected by local law. 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 DisabilityAccommodationscatalent.com . 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. Summary Location: Nottingham, United Kingdom Type: Full time