QA Validation Specialist

Position Summary: Catalent Pharma Solutions is hiring a QA Validation Specialist for our site in Morrisville, NC. This is a full-time role position: Monday – Friday, days. Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays. 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 Review and approve computer validation projects related to authoring and executing specifications and validation documentation for laboratory automated equipment and systems according to the GAMP5 Validation Life Cycle (URS, FRS, DS (Software and Hardware), Commissioning, IQ, OQ, PQ), and other validation reports Review and approve risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan Review and approve computer system validation on specific laboratory equipment such as HPLC’s, Empower documents, etc. Perform all other tasks according to “standard work” as defined by reporting manager. The Candidate BS in Engineering, Chemistry, or other related scientific discipline 5 years of experience with reviewing GMP documents Must have knowledge of current industry expectations of validation requirements for process validation, cleaning validation, computer validation, and equipment qualification Ability to handle multiple projects and deliver on project timelines with supervision Knowledge of all current cGMP requirements in the US and other parts of the world Understanding of statistical evaluation tools Self-starter who exhibits a professional demeanor, enthusiasm, communications, and the ability to work independently with minimal supervision Sound knowledge and experience of pharmaceutical industry standards and requirements Work well in cross-functional departments Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture 19 days of PTO 8 paid holidays Dynamic, fast-paced work environment Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Competitive salary Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement GymPass program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900 merchants in a wide array of categories 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 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. Catalent = Catalyst Talent Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! personal initiative. dynamic pace. meaningful work. Catalent is the perfect place to grow your career if… You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT). You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world! You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people. You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first. You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU! See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.

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