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Kyowa Kirin, Inc.- U.S. · 9 hours ago

Computer System Validation (CSV) Engineer III

Sanford, NC

Full-time

Onsite

Mid, Senior Level

$106K/yr - $139K/yr

5+ years exp

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. The CSV Engineer will support all CSV of Commissioning, Qualification and Verification activities for the NC Manufacturing Facility, focusing initially on a LIMS implementation and associated integrations.

Pharmaceuticals

H1B Sponsor Likely

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: LIMS, Veevao, D365, MES / PCS / BMS / DHisto, ValGenesis, Cloudo, 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

Qualification

CSVLIMSCGMP regulationsMS Office SuiteData IntegrityTech TransferAnalytical SkillsGAMPEHSSoft Skills

Required

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

Background in cGMP regulations, GAMP, EHS

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

Preferred

Experience with Tech Transfer is a plus

Experience operating within a start up biopharma manufacturing facility is a plus

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

Company

Kyowa Kirin, Inc.- U.S.

Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines.

Founded in 1949

Princeton, New Jersey, US

501-1000 employees

https://kkna.kyowakirin.com/

H1B Sponsorship

Kyowa Kirin, Inc.- U.S. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2022 (1)

2021 (1)