Associate Director, Pharmaceutical Manufacturing Plant ...

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: As the Manufacturing Site IT Infrastructure Lead, your role will be to own and manage the planning, implementation, and execution of IT infrastructure at the new manufacturing site. You will be responsible for helping stand up the new state-of-the-art facility, ensuring the infrastructure (including Manufacturing IT networks), network, and mobile strategy drives the site objectives and aligns to NA and enterprise standards. This role will be responsible for both the manufacturing and the site office space infrastructure. This technical role requires deep infrastructure experience from strategic planning to tactical implementation, technical support, and ongoing change in a Life Sciences Manufacturing environment. Essential Functions: * Technical lead and responsible for network operations, server administration, security, and end-user support for manufacturing, lab, and office users * Design, implement, and maintain a robust, scalable, and redundant enabled network infrastructure that supports real-time manufacturing operations and accommodates mobile device integration. * Support the implementation and maintenance of the virtual server infrastructure for "on premises" servers. * Support the implementation and management of the cloud server infrastructure as required by the business, management of firewalls, and how to secure and separate manufacturing, lab, and office networks as required. * Management of IT Infrastructure of shop floor and plant automation systems such as Process Control Systems, Manufacturing Execution Systems, Data Historians, and Building Management Systems * Proactively identify and resolve network issues, minimizing downtime and ensuring optimal system performance * Develop and implement a site-specific IT infrastructure strategy that aligns with the North American and global enterprise strategy, standards and methods director's role * Ensure compliance with regulatory requirements and BI / external standards (EHS, Corporate procedures, GxP etc.) * Stay up to date with the latest technology trends and advancements in the pharma and manufacturing industry * Develop the site IT strategy and planning in line with global manufacturing IT strategy and roadmap strategy and planning is the director's role. * Collaborate with global manufacturing IT team to build and execute the integrated IT roadmap as needed. * Manage vendor relationships and negotiate contracts for IT services and equipment. * Provide technical support and troubleshooting assistance to end-users. * Translate business requirements to technical requirements in support of project execution. * Work with the various system owners to create and maintain the computer systems inventory. * Support the Site IT Director in creating a Life Cycle Management and maintenance program to ensure all IT Server and Infrastructure hardware is maintain up to date and supported by mainstream vendors Requirements: Education Bachelor's degree in information technology, Computer Science or a related field a plus Experience At least 7 years of overall IT experience with at minimum 3 years working in Manufacturing. Proven experience in IT Infrastructure technical lead roles, in a manufacturing and pharma environment. Demonstrated experience in network and firewall design, network segregation and maintenance. Strong knowledge across several IT disciplines including, Network, Security, Infrastructure, and Manufacturing Systems. Strong understanding of network security protocols and best practices.. Good working knowledge of virtual server environments. Experience with the cloud server infrastructure. Experience with network monitoring and troubleshooting tools. Hands on experience of effective methodologies for Data Back Up and Restore, Data Archive and Retrieval, and Server Image Back up and Restore. Knowledge of data security, cyber security standards and trends and compliance regulations. Strong understanding and technical application of Good Manufacturing Practice (GMP) regulations and regulatory guidance for industry and network impact. Experience working for international companies with multi-cultural background and diversified environment. Technical Skills Proficient in MS Office Suite KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It 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 . Controller's data protection officer can be contacted at . 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 . Recruitment & Staffing Agencies Kyowa 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 #On-Site

Created: 2024-11-05