Lead Validation Engineer

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, Protoc