Equipment Qualification Validation and Computer System ...

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.Summary:The EQV/CSV Lead will lead the Commissioning, Qualification and Verification of our NC Manufacturing Facility. Post project implementation, the EQV/CSV Lead will be responsible for EQV/CSV activities at the site as it transitions into routine operations. In this role, you will collaborate closely with our team, demonstrating compassion and integrity in all your work. You will utilize your ability to facilitate alignment among diverse viewpoints to make informed decisions and drive consensus. By fostering a positive and inclusive environment, you'll navigate change and uncertainty with resilience and clarity, contributing to your team's ability to adapt to rapidly evolving, fast-scaling environments and meet new challenges in the biotech industry.Essential Functions:•Develop the establishment of the EQV/CSV program for the Sanford site.•Supports the implementation of selected e-validation solution.•Drives execution with the other functional leads of the capital project, delivering an 'OQ complete' status of the facility by Q1 2027Requirements:EducationBachelor's degree in a technical field required. Formal GMP and Safety training is essential.ExperienceAt least 10 years of experience in CQV for BioPharma Manufacturing or Capital Projects. Leadership experience in CQV is a must. Experience with Tech Transfer is a plus. Background in cGMP regulations, GAMP, EHS.Technical SkillsProficient in MS Office SuiteKKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactionsIt is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@. Controller's data protection officer can be contacted at usprivacyoffice@. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@.Recruitment & Staffing AgenciesKyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.LI-TT1 #Sanford #North Carolina

Created: 2024-10-19