Lead Validation Engineer Jobs (NOW HIRING)

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.

Summary of Job:

The Lead Validation Engineer will lead the day-to-day activities for CQV of process equipment, facilities, utilities, and automation systems at the NC Manufacturing Facility. Following project implementation, the Lead Validation Engineer will be responsible for EQV/CSV activities at the site as it transitions into further tech transfer activities and routine operations. The Lead Validation Engineer will also support process validation, cleaning validation, or shipping validation activities.
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. The Lead Validation Engineer will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, as the Lead Validation Engineer, 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.

Essential Functions:

Technical Skills, Knowledge, and Experience Commissioning & Qualification (CQ)
Develop and implement commissioning and qualification strategies for:
o Manufacturing equipment
o Process equipment
o Facilities and cleanrooms
o Critical utilities (HVAC, WFI, compressed gases, etc.)
Oversee day-to-day activities for execution of DQ, IQ, OQ, and PQ
Oversee generation of equipment and system lifecycle document generation
Ensure traceability to user requirements and regulatory expectations
Support startup, tech transfer, and commercial readiness activities
Computer System Validation (CSV)
Lead day-to-day activities for validation of computerized systems including:
o Manufacturing Execution Systems (MES)
o Quality systems (EDMS)
o Automation and control systems (PLC, SCADA, DCS)
Ensure compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11
Approve validation plans, risk assessments, protocols, and final reports
Perform data integrity assessments and periodic reviews Process, Cleaning, and Shipping Validation
Develop and implement site process, cleaning and shipping validation programs
Drive completion of process validation, cleaning validation and shipping validation activities to support commercial operations Compliance & Quality
Ensure validation lifecycle documentation meets regulatory and internal quality standards
Support regulatory inspections and audits (FDA, EMA, MHRA, etc.)
Address audit observations, deviations, CAPAs, and change controls related to validation
Drive use of risk-based validation approaches and continuous improvement initiatives Project & Stakeholder Management
Partner with Engineering, IT, Quality, Manufacturing, and Automation teams
Support capital projects, expansions, and new product introductions
Support tech transfer and process validation activities
Provide clear communication and reporting to team members and area functional leads

Job Requirements:

Education and Experience
The following combination of education and professional experience is required for this role:
o Bachelor's degree in a technical field required. Formal GMP and Safety training is essential.
o At least 7 years of experience in CQV for BioPharma Manufacturing or Capital Projects, with experience validating process equipment, facilities, utilities, and automation systems. Experience with leading validation for projects is essential. Experience with Process Validation, Shipping Validation, Cleaning Validation or Tech Transfer is a plus.
o Experience working with and leading a small group of contractors or consultants
Technical Skills:
Proficient in MS Office Suite
Knowledgeable in cGMPs, GAMP, Safety Practices, Regulatory Compliance, Protocol Development and Execution, Risk Assessment, Criticality Assessment and System Turnover/Training.
Experience using a digital validation lifecycle management system

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.

Physical Demands: Initially, position requires working on a construction site and will ultimately transition to the biotech manufacturing site in Sanford, NC.
Work is 100% on-site. This is not a hybrid or remote role.

Working Conditions: May require up to 10% domestic and limited international travel

The anticipated salary for this position will be $145,100 to $177,300.  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
• 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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