Lead Validation Engineer
Not Disclosed•Full-TimeOn-site
location_onOn-site
About Kyowa Kirin
Kyowa Kirin is a fast-growing global specialty pharmaceutical company dedicated to translating science into smiles. We apply state-of-the-art biotechnologies to discover and deliver novel medicines in four key disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. Our mission is to provide therapies where no adequate treatments currently exist, covering the entire journey from drug discovery to product development and commercialization.
Headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario, we are committed to acting with integrity and in accordance with the law in all our operations. We foster a supportive and inclusive environment where diverse viewpoints are valued, and we prioritize the needs of patients at the center of our efforts.
Work location
Work model: On-site
On-site
Key Responsibilities
- check_circleDevelop and implement commissioning and qualification strategies for manufacturing equipment, facilities, and utilities
- check_circleOversee day-to-day execution of DQ, IQ, OQ, and PQ activities for process equipment and systems
- check_circleApprove validation plans, risk assessments, protocols, and final reports for equipment and software
- check_circleDevelop and implement site process, cleaning, and shipping validation programs to support commercial operations
- check_circlePartner with Engineering, IT, Quality, and Manufacturing teams to support capital projects and tech transfer activities
- check_circleEnsure validation lifecycle documentation meets regulatory standards and supports FDA, EMA, and MHRA inspections
- check_circleLead validation activities for computerized systems including MES, EDMS, and automation control systems
Requirements
- verifiedBachelor's degree in a technical field
- verifiedFormal GMP and Safety training
- verifiedAt least 7 years of experience in CQV for BioPharma Manufacturing or Capital Projects
- verifiedExperience validating process equipment, facilities, utilities, and automation systems
- verifiedExperience leading validation for projects
- verifiedProficient in MS Office Suite
- verifiedKnowledge of cGMPs, GAMP, Safety Practices, Regulatory Compliance, Protocol Development and Execution, Risk Assessment, Criticality Assessment and System Turnover/Training
- verifiedExperience using a digital validation lifecycle management system
Nice to Have
Experience with Process Validation, Shipping Validation, Cleaning Validation or Tech Transfer.
Benefits & Perks
check_circle401K with company matchingcheck_circleAnnual Bonus Programcheck_circleGenerous PTO and Holiday Schedule including Summer and Winter Shut-Downs, Sick Days, and Volunteer Dayscheck_circleHealthcare Benefits including Medical, Dental, Prescription Drugs, and VisionHSA & FSA Programs
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Skills, education and keywords
Skills: MS Office Suite, CGM, Gamp, Safety Practices, Regulatory Compliance, Protocol Development, Protocol Execution, Risk Assessment, Criticality Assessment, System Turnover.
Education: Bachelor's degree in a technical field required.
Frequently asked questions about Lead Validation Engineer at Kyowa Kirin, Inc.- U.S.
What does a Lead Validation Engineer at Kyowa Kirin, Inc.- U.S. do?expand_more
Day-to-day, the Lead Validation Engineer at Kyowa Kirin, Inc.- U.S. will develop and implement commissioning and qualification strategies for manufacturing equipment, facilities, and utilities; oversee day-to-day execution of dq, iq, oq, and pq activities for process equipment and systems; approve validation plans, risk assessments, protocols, and final reports for equipment and software; and develop and implement site process, cleaning, and shipping validation programs to support commercial operations.
What are the requirements for this Lead Validation Engineer role?expand_more
To qualify for the Lead Validation Engineer at Kyowa Kirin, Inc.- U.S. position, applicants should have: Bachelor's degree in a technical field; Formal GMP and Safety training; At least 7 years of experience in CQV for BioPharma Manufacturing or Capital Projects; Experience validating process equipment, facilities, utilities, and automation systems; Experience leading validation for projects; and Proficient in MS Office Suite.
Where is the Lead Validation Engineer role at Kyowa Kirin, Inc.- U.S. located?expand_more
Lead Validation Engineer at Kyowa Kirin, Inc.- U.S. is based in On-site. This is a on-site role.
Is this Lead Validation Engineer job remote, hybrid, or on-site?expand_more
Kyowa Kirin, Inc.- U.S. has listed this Lead Validation Engineer role as on-site.
How much experience is required for this Lead Validation Engineer role?expand_more
Lead Validation Engineer at Kyowa Kirin, Inc.- U.S. typically requires 7+ years of relevant experience at the lead level.
What skills do you need for the Lead Validation Engineer role at Kyowa Kirin, Inc.- U.S.?expand_more
Key skills for Lead Validation Engineer at Kyowa Kirin, Inc.- U.S. include MS Office Suite; CGM; Gamp; Safety Practices; Regulatory Compliance; Protocol Development; Protocol Execution; and Risk Assessment.
What education is required for Lead Validation Engineer at Kyowa Kirin, Inc.- U.S.?expand_more
Educational requirements for this role: Bachelor's degree in a technical field required.
What category does the Lead Validation Engineer role belong to?expand_more
Lead Validation Engineer at Kyowa Kirin, Inc.- U.S. is part of the engineering job category on Recrutus.
About Kyowa Kirin, Inc.- U.S.
Kyowa Kirin, Inc.- U.S. operates as a global specialty pharmaceutical manufacturer headquartered in Princeton, New Jersey. The organization leverages advanced biotechnologies to discover and deliver novel medicines, focusing specifically on treating complex and difficult-to-manage diseases. By addressing areas with high patient need, the company aims to create therapies capable of generating life-changing impacts for individuals suffering from severe conditions.
The North American division maintains a strategic footprint with offices in Princeton, New Jersey, and Toronto, Canada, alongside a research facility located in La Jolla, California. This regional team collaborates to identify clinical needs and advance innovations that significantly affect patient outcomes. The company fosters an environment where entrepreneurial professionals contribute their expertise and ideas to shape the work being done.
Core values such as innovation, diversity, integrity, and the cultural concept of wa guide the organization's operations. Employees play a vital role in determining the results delivered to the market. The company remains committed to its mission of improving lives through scientific advancement and collaborative effort within the pharmaceutical industry.
Browse more roles: All Kyowa Kirin, Inc.- U.S. jobs, engineering jobs on Recrutus.