Lead Validation Engineer

1d1 day ago

Kyowa Kirin

Sanford, US · Full-time · $145,100 – $177,300

About this role

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in bone and mineral, intractable hematologic, hematology oncology, and rare disease. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

The Lead Validation Engineer will lead the day-to-day activities for commissioning and qualification of process equipment, facilities, utilities, and automation systems at the NC Manufacturing Facility. Following project implementation, this role will be responsible for equipment and computer system validation as the site transitions into further tech transfer activities and routine operations.

As an individual contributor, you will take a compassionate and people-focused approach, proactively collaborating with others to create a supportive and inclusive environment. 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. You will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow while keeping the needs of patients at the center of your efforts.

Requirements

Proven experience leading commissioning and qualification activities for process equipment, facilities, utilities, and automation systems in a pharmaceutical or biotech manufacturing environment
Strong knowledge of computer system validation (CSV) including GAMP 5, 21 CFR Part 11, and EU Annex 11 compliance
Experience with process validation, cleaning validation, and shipping validation programs
Ability to perform data integrity assessments and periodic reviews
Demonstrated ability to support regulatory inspections and audits (FDA, EMA, MHRA, etc.)
Experience with risk-based validation approaches and continuous improvement initiatives
Strong interpersonal skills to collaborate effectively with cross-functional teams including Engineering, IT, Quality, Manufacturing, and Automation

Responsibilities

Develop and implement commissioning and qualification strategies for manufacturing equipment, process equipment, facilities and cleanrooms, and critical utilities (HVAC, WFI, compressed gases, etc.)
Oversee day-to-day activities for execution of DQ, IQ, OQ, and PQ, and generation of equipment and system lifecycle documentation
Lead day-to-day activities for validation of computerized systems including MES, EDMS, and automation/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
Develop and implement site process, cleaning, and shipping validation programs to support commercial operations
Support regulatory inspections and audits (FDA, EMA, MHRA, etc.) and address audit observations, deviations, CAPAs, and change controls related to validation
Partner with Engineering, IT, Quality, Manufacturing, and Automation teams to support capital projects, expansions, and new product introductions

Benefits

Opportunity to work at a state-of-the-art NC Manufacturing Facility
Be part of a fast-growing global specialty pharmaceutical company with a people-focused culture
Work on novel medicines in four disease areas where no adequate treatments currently exist
Supportive and inclusive environment that values diverse viewpoints and thoughtful relationship management