**Validation Specialist** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Catalent’s Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. The Validation Specialist provides support and oversite of Process/Cleaning validation activities for all drug products/APIs being commercialized. The Validation Specialist performs all validation activities including drafting and approving documents, execution of protocols on the manufacturing floor, drafting reports, attending customer meetings, supporting customer audits, and meeting manufacturing timelines. Working Hours: Monday-Friday 8 AM-5 PM. This role will be 100% on-site in Winchester, Kentucky. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. **The Role** + Draft protocols and reports for Process Validation and/or Cleaning Validation. Responsibilities include developing the appropriate and required protocol documents in accordance with the current site and corporate Validation SOP’s and guidelines. Obtaining approval signatures from the Catalent management and as required from customers. + Execute approved protocols and coordinate the activities with other departments (e.g. engineering, maintenance, production, etc…) as required. + Review and approve site Annual Product reviews. + Assists in site NPIx gate reviews. + Involvement with customer audits and responding to audit observations and corrective actions. + Assist in investigations of manufacturing / facility deviations as asked of by Quality Systems. + Addressing process/facility Change Controls issued. Addressing process/facility CAPAs issued. + Interacts with customers, including participating in scheduled teleconferences and responding to customer requests/complaints. + Other duties as required. **The Candidate** + Associates degree in life sciences (e.g., Pharmaceuticals, Chemistry, Biology, etc.) or related field required with 2 years experience in the Pharmaceutical/ Biotechnology or Medical Devices industry. Bachelor's Degree preferred. + Experience in authoring, reviewing and approving of validation deliverables including Risk Assessments, Test Plans, Protocols, Reports, Summary Reports and Standard Operating Procedures (SOPs). + Knowledge of validation SOPs and site policies associated to their area. + Requires excellent computer skills and general knowledge of computerized systems. + Scientific writing skills + Knowledge of cGMP guidelines and regulations, proficiency in Microsoft Word, PowerPoint and Excel, working knowledge of TrackWise and EDMS systems. + Individual may be required to sit for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor. Sustained sitting at desk or workstation with use of phones, computers and any other office equipment required for specified position. Static stance/standing as required. File/Folder storage with non-repetitive light weight lifting, reaching and forward bending as necessary. Infrequent lifting overhead reaching less than or equal to 15lbs with the ability to potentially be able to lift up to 35lbs and push/pull 40lbs **Why You Should Join Catalent** + Several Employee Resource Groups focusing on D&I + Tuition Reimbursement – Let us help you finish your degree or earn a new one! + Generous 401K match + 152 hours 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. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.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. 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 HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .