Equipment Validation Engineer 2

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 were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays 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 youll find a home here where your efforts directly improve patients lives. Together lets 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 70000 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: Description

What Youll 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:

• Bachelors degree in Engineering (Mechanical Chemical Electrical Biomedical Industrial) or related scientific field.
• 25 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 Q8Q10 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 2540 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 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 ().

Required Experience:

IC