Computer System Validation; CSV Engineer II

Overview

Sanford, NC

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. 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 Commissioning, Qualification and Verification activities for the NC Manufacturing Facility. The initial area of focus for this role will 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, proactively collaborate with others, and act in line with the organization’s values. You will deliver results, adapt to challenges, own tasks, and seek opportunities to learn and grow while keeping the needs of patients at the center of your efforts.

This role reports into the Associate Director, CQV Site Lead.

• Execute the ongoing development and maintenance of the EQV/CSV/CSA/DI program for the Sanford site.
• Execute the implementation and qualification of selected analytical system solutions and integrations.
• Lead EQV/CSV/CSA/DI programs for capital projects, site changes, and technological implementations, ensuring alignment with site and global computer system validation requirements and industry practices to maintain a compliant facility.
• Drive CSV and integrations including LIMSs, Veeva, D365, MES / PCS / BMS / DHist, Val Genesis, Cloud, IT/OT.
• Lead ongoing maintenance and continuous improvement of all qualified automation and computerized systems once the site becomes operational, ensuring continued compliance with cGMP standards and regulatory requirements.

• The following combinations are required:
• Bachelor’s degree in a technical field with at least 3 years of CQV experience for Bio Pharma Manufacturing or Capital Projects.
• Associate’s degree in a technical field with at least 4 years of CQV experience for Bio Pharma Manufacturing or Capital Projects.
• High School degree may be considered with at least 6 years of CQV direct related experience in Bio Pharma Manufacturing and/or Capital Projects.
• Formal GMP and Safety training is essential.
• 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.

• Proficient in MS Office Suite
• Familiar with Azure Cloud, POMSnet Aquila MES / Ignition PCS / Ignition EMS / Schneider Eco Struxure Building Operation BMS / Delta
  
  V / Canary Axiom Data Historian / PLCs
• Strong analytical skills to identify business requirements and provide solutions to complex issues
• Strong working knowledge of regulations for computerized systems, data integrity (e.g., 21
  
  CFRPart 11, EU Annex 11, FDA/PICS Data Integrity Guidance, GAMP5)
• Demonstrated knowledge of CSV/CSA applications and regulations

• Results-oriented and able to navigate ambiguity; set clear outcomes, track progress, and ensure actions lead to measurable results
• Respond promptly, take accountability, manage tasks efficiently, and adapt to change with clarity
• Exhibit strong organizational skills, attention to detail, and a solid work ethic while fostering a global, inclusive environment
• Communicate with care, actively listen, and consider diverse perspectives
• Commit to continuous learning, knowledge sharing, and a growth mindset
• Promote inclusive collaboration, respect diverse perspectives, and prioritize collective success
• Be resourceful, proactive, and drive innovation with a holistic, enterprise-wide mindset

Initially, position requires working on a construction site and will transition to the biotech manufacturing site in Sanford, NC. Work is 100% on-site. Requires up to 10% domestic and…