Lead Validation Engineer

Kyowa Kirin North America • Sanford, NJ

9h • Onsite

About The Position

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.

Requirements

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

Nice To Haves

• Experience with Process Validation, Shipping Validation, Cleaning Validation or Tech Transfer is a plus.
• Experience working with and leading a small group of contractors or consultants

Responsibilities

• Develop and implement commissioning and qualification strategies for: Manufacturing equipment, Process equipment, Facilities and cleanrooms, 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
• Lead day-to-day activities for validation of computerized systems including: Manufacturing Execution Systems (MES), Quality systems (EDMS), 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
• 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
• 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
• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior