Computer System Validation (CSV) Engineer III at KYOWA KIRIN INC

Sanford, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Apr, 26

Salary

138800.0

Posted On

10 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Computer System Validation, Analytical Skills, Project Management, Collaboration, Data Integrity, Regulatory Compliance, Technical Transfer, GMP Regulations, Cloud Technologies, LIMS, MES, D365, Veeva, Continuous Improvement, Problem Solving, Communication, Organizational Skills

Industry

Pharmaceutical Manufacturing

Description

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 translate science into smiles by delivering therapies 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, North Carolina, and Mississauga, Ontario. The CSV Engineer will support all CSV of Commissioning, Qualification and Verification activities for the NC Manufacturing Facility. The initial area of focus for this role will initially be in the analytical space, supporting a LIMS implementation, and the associated instrument and ancillary system integrations. Post project implementation, the Engineer will be responsible for supporting all EQV/CSV activities at the site as it transitions into routine operations. As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts. This role reports into the Site EQV/CSV Lead Technical Skills, Knowledge, and Experience • Executes the ongoing development and maintenance of the EQV/CSV/CSA/DI program for the Sanford site. • Executes the implementation and qualification of selected analytical system solutions and integrations. • Lead EQV/CSV/CSA/DI programs for various initiatives including: capital projects, site changes, technological implementations. etc.; ensuring alignment with site and global computer system validation requirements and industry practices to maintain a compliant facility.” • Drives CSV and integrations associated with: o LIMSs o Veeva o D365 o MES / PCS / BMS / DHist o ValGenesis o Cloud o IT/OT • Once the site becomes operational, lead ongoing maintenance and continuous improvement of all qualified automation and computerized systems, ensuring continued compliance with cGMP standards, regulatory requirements, and company procedures. Individual contributor with the opportunity to potentially lead or coordinate task teams. Education • Bachelor’s degree in a technical field required. Formal GMP and Safety training is essential. Experience • At least 5 years of experience in CQV for BioPharma Manufacturing or Capital Projects. Experience with Tech Transfer is a plus. Background in cGMP regulations, GAMP, EHS. • Experience operating within a start up biopharma manufacturing facility is a plus. Technical Skills • Proficient in MS Office Suite • Familiar with Azzure Cloud, POMSnet Aquila MES / Ignition PCS / Ignition EMS / Schneider EcoStruxure Building Operation BMS / DeltaV / Canary Axiom Data Historian / PLCs • Strong analytical skills to identify business requirement and to provide solutions to complex issues. • Strong working knowledge of regulations for computerized systems, data integrity (e.g., 21CFRPart 11, EU Annex 11, FDA/PICS Data Integrity Guidance, GAMP5) • Knowledge of CSV/CSA applications and regulations Non-Technical Skills Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions. Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC. Work is 100% on-site. This is not a hybrid or remote role. The anticipated salary for this position will be $106,300 to $138,800. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: 401K with company matching Discretionary Profit Sharing Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) HSA & FSA Programs Well-Being and Work/Life Programs Long-Term Incentive Program (subject to job level and performance) Life & Disability Insurance Concierge Service Pet Insurance Tuition Assistance Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 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 kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. 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@kyowakirin.com. 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-SH1

Responsibilities

The CSV Engineer will support all CSV activities for the NC Manufacturing Facility, focusing initially on a LIMS implementation and associated integrations. Post-implementation, the Engineer will lead ongoing maintenance and continuous improvement of all qualified automation and computerized systems.