Computer System Validation (CSV) Engineer III

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 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 organizations 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
Bachelors 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$106300 to $138800. 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.

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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.

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