Computer System Validation (CSV) Engineer III

Kyowa Kirin North America•Sanford, NC

1d•Onsite

About The Position

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

Requirements

Bachelor’s degree in a technical field required. Formal GMP and Safety training is essential.
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.
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
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.

Nice To Haves

Experience with Tech Transfer is a plus.
Experience operating within a start up biopharma manufacturing facility is a plus.

Responsibilities

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.

Benefits

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