Equipment Validation Engineer 2

FUJIFILM; Northern (KY); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking an Equipment Validation Engineer II to support qualification of manufacturing equipment and utilities in a GMP facility. You will develop risk-based validation strategies, author and run IQ/OQ/PQ protocols, and collaborate with cross-functional teams to ensure compliant, reliable operations.

Responsibilities include leading validation and re-qualification, developing test methods, data analysis, and maintaining ALCOA+ documentation.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 2–5+ years of hands-on validation in regulated environments (pharma, biotech, medical device, CDMO).
• Demonstrated experience authoring and executing IQ/OQ/PQ protocols and validation reports.
• Strong working knowledge of cGMP and applicable regulations/standards: FDA 21 CFR Parts 210/211/820, ICH Q8–Q10, Annex 15, GAMP 5, ISO 13485/9001; data integrity principles.
• Familiarity with risk management tools (FMEA, HACCP, Fault Tree), statistics (GR&R, capability, sampling justification), and DOE basics.
• Experience with utilities and process equipment; understanding of calibration, metrology, and measurement traceability.
• Proficiency with validation and quality systems (eQMS/EDMS), CMMS, and basic scripting/spreadsheet analysis; strong technical writing.

Responsibilities

• Author, review, and execute validation deliverables: URS, risk assessments (FMEA), validation plans, IQ/OQ/PQ protocols, reports, deviation investigations, and change controls.
• Lead validation and re-qualification for new and existing equipment, utilities, and systems (e.g., fermenters, autoclaves, vessels, CIP/SIP, WFI/clean steam, environmental chambers).
• Lead and execute the site re-qualification program.
• Perform equipment/system impact assessments and determine validation strategies based on risk and regulatory requirements.
• Develop and implement test methods, acceptance criteria, sampling plans, and data collection tools; perform data analysis and write summary reports.
• Ensure calibration and preventive maintenance requirements are defined, documented, and integrated with CMMS/Metrology.
• Troubleshoot equipment performance issues; partner with Maintenance/Engineering for root cause analysis and CAPA implementation.
• Maintain compliant documentation within electronic quality systems (e.g., Trackwise, Veeva, KNEAT) and ensure data integrity (ALCOA+).
• Support CSV/automation aspects where applicable (PLC/HMI, SCADA, data historians, audit trails, backups, user access).
• Execute validation activities under change control, author justifications, and assess validation impact for changes, deviations, and nonconformances.
• Support internal and external audits; present validation rationale, evidence, and traceability.
• Contribute to SOP/work instruction development, templates, and validation standards; drive continual improvement and harmonization.
• Coordinate vendor FAT/SAT and onsite qualification as required.
• Ensure EHS compliance during equipment commissioning, start‑up, and qualification activities.

Skills

IQ/OQ/PQ

Regulatory compliance

Risk assessment

Technical writing

Root cause analysis

Cross-functional collaboration

DOE basics

Metrology & calibration

Scripting/Spreadsheet analysis

Education

Bachelor’s degree in Engineering or related field

Tools

CMMS

eQMS/EDMS

Trackwise

Veeva

KNEAT

Statistical software

Job description

Position Overview

We are seeking an Equipment Validation Engineer II to support the qualification of manufacturing equipment and utilities in our GMP facility. You will develop and execute risk-based validation strategies, author and run IQ/OQ/PQ protocols, and partner with cross-functional teams to ensure compliant, reliable operations.

Company Overview

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do:

• Author, review, and execute validation deliverables: URS, risk assessments (FMEA), validation plans, IQ/OQ/PQ protocols, reports, deviation investigations, and change controls.
• Lead validation and re-qualification for new and existing equipment, utilities, and systems (e.g., fermenters, autoclaves, vessels, CIP/SIP, WFI/clean steam, environmental chambers).
• Lead and execute the site re-qualification program.
• Perform equipment/system impact assessments and determine validation strategies based on risk and regulatory requirements.
• Develop and implement test methods, acceptance criteria, sampling plans, and data collection tools; perform data analysis and write summary reports.
• Ensure calibration and preventive maintenance requirements are defined, documented, and integrated with CMMS/Metrology.
• Troubleshoot equipment performance issues; partner with Maintenance/Engineering for root cause analysis and CAPA implementation.
• Maintain compliant documentation within electronic quality systems (e.g., Trackwise, Veeva, KNEAT) and ensure data integrity (ALCOA+).
• Support CSV/automation aspects where applicable (PLC/HMI, SCADA, data historians, audit trails, backups, user access).
• Execute validation activities under change control, author justifications, and assess validation impact for changes, deviations, and nonconformances.
• Support internal and external audits; present validation rationale, evidence, and traceability.
• Contribute to SOP/work instruction development, templates, and validation standards; drive continual improvement and harmonization.
• Coordinate vendor FAT/SAT and onsite qualification as required.
• Ensure EHS compliance during equipment commissioning, start‑up, and qualification activities.

Required Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, Industrial) or related scientific field.
• 2–5+ years of hands‑on validation experience in regulated environments (pharma, biotech, medical device, CDMO, or related).
• Demonstrated experience authoring and executing IQ/OQ/PQ protocols and validation reports.
• Strong working knowledge of cGMP and applicable regulations/standards: FDA 21 CFR Parts 210/211/820, ICH Q8–Q10, Annex 15, GAMP 5, ISO 13485/9001; data integrity principles.
• Familiarity with risk management tools (FMEA, HACCP, Fault Tree), statistics (e.g., GR&R, capability, sampling justification), and DOE basics.
• Experience with utilities and process equipment; understanding of calibration, metrology, and measurement traceability.
• Proficiency with validation and quality systems (eQMS/EDMS), CMMS, and basic scripting/spreadsheet analysis; strong technical writing.

Preferred Experience:

• Aseptic processing, manufacturing processing, sterilization (SIP/CIP, moist/dry heat), cleaning validation, and environmental monitoring.
• Prior involvement in tech transfers, scale‑up, or new product introductions.
• Experience working with engineering firms, equipment manufacturers, and outside vendors.

Core Competencies:

• Risk-based, detail‑oriented approach with strong problem‑solving and root‑cause skills.
• Strong verbal and written communication skills.
• Cross‑functional collaboration.
• Ability to manage multiple projects, priorities, and timelines with minimal supervision.
• Veeva, KNEAT, CMMS, Trackwise experience preferred.
• Work Environment and Physical Requirements
• Onsite presence during commissioning/qualification; periodic off‑shift/weekend support during start‑ups.

Physical Demands:

• Ability to lift up to 25–40 lbs occasionally, work in cleanroom or controlled environments, and wear appropriate PPE.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via‑email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).