Senior Engineer 1/2, CQV Upstream & Downstream

Position Overview

The Senior CQV Engineer 1 leads the commissioning and qualification of equipment and systems of assigned area for the site. This role performs and leads the CQV team through the validation lifecycle, investigation of deviations and root cause analyses, and establishes standard operating procedures and other documents. This role collaborates with internal and external stakeholders to ensure strategies, equipment, and systems incorporate global standards and align and comply with regulatory requirements and quality standards. Additionally, this role provides training and guidance to junior engineers to ensure successful integration of CQV activities into site projects.

The Senior Engineer 2, CQV serves as a subject matter expert and leads the commissioning and qualification of equipment and systems for multiple areas of the site. This role performs and leads the CQV team through the validation lifecycle, investigation of deviations and root cause analyses, and establishes standard operating procedures and other documents. This role partners with internal and external stakeholders to ensure strategies, equipment, and systems incorporate global standards and align and comply with regulatory requirements and quality standards. Additionally, this role provides training and guidance to junior engineers to ensure successful integration of CQV activities into site projects.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

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:

Job Description

What You'll Do

• Acts as CQV Technical Lead for process support equipment to establish validation strategies, develop validation procedures that align with FDB's Large Scale Biologics platform operating principles and regulatory requirements.
• Provides guidance and leads the management of validation lifecycle for responsible areas for process support equipment and warehouse during Installation Verification (IV), Operational Verification (OV), Installation & Operational Qualification (IOQ), Performance Qualification (PQ) through Good Manufacturing Practices (GMP) release to decommissioning.
• Provides technical support and leads external validation engineers through commissioning, qualification and validation of Large-Scale Biologics facilities and equipment.
• Participates with FUJIFILM Biotechnologies cross-network to inform and influence strategic management of validation programs, and working knowledge to incorporate global standards at the site level.
• Liaises and collaborates with key stakeholders and support groups (e.g., Manufacturing, Process Science, Automation, Supply Chain, and Quality) to ensure FDB validation requirements are met.
• Collaborates cross-functionally to ensure successful integration of CQV activities into projects.
• Establishes Validation standard operating procedures (SOPs), Validation Project Plan (VPP), and Validation Master Plan (VMP) to ensure full cGMP compliance by operations launch.
• Liaises with CQV Document Generation Lead to generate and approve DQ, Design Reviews, SLIA, Test Matrices, Risk Assessments, QA Vendor Assessments, FAT, SAT, CTP, and IOQ Protocols.
• Leads the investigation of qualification deviations or discrepancies utilizing problem solving, and root cause analysis (RCA) to properly identify root causes and develop remediation plans (e.g., corrective and preventive action (CAPAs)).
• Performs change control validation assessments to determine risk-based qualification, requirements for new systems, and changes to existing qualified systems.
• Conducts impact and risk assessments and identifies risks and develops and leads the implementation of mitigation strategies.
• Provides guidance and training to junior engineers for all CQV-related activities, as needed.
• Other duties, as assigned.

Additional Senior Engineer II Responsibilities

• Participates in the Global subject matter expert (SME) Network to ensure cross-site alignment for CQV.
• Prepares presentation packages for FDBN's Validation Lifecycle program for internal and external audits and client visits and participates in presenting, as required.

Knowledge, Skills, and Abilities

• Effective communication, both written and oral.
• Ability to effectively present information to others.
• Proficient knowledge of Microsoft Office (e.g., Word, PowerPoint).
• Knowledge of industry guidelines International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), United States and international regulations such as Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), ISO, EU) for validation of GMP facilities.

Additional Senior Engineer II Skills and Abilities

• Ability to develop effective working relationships internally and externally.
• Advanced strategic planning and problem-solving skills.

Minimum Qualifications

Senior Engineer I:

• Bachelor's degree in Engineering.
• 8 years of experience in validation activities in facilities, commissioning, and systems qualifications.
• Experience with cGMP or working in another highly regulated industry.

Senior Engineer II:

• Bachelor's degree in Engineering.
• 12 years of experience in validation activities in facilities, commissioning, and systems qualifications.
• Experience with cGMP or working in another highly regulated industry.

Preferred Qualifications

Senior Engineer I:

• Master's degree in Engineering with 6 years of experience in validation activities in facilities, commissioning, and system qualifications.

Senior Engineer II:

• Master's degree in Engineering with 8 years of experience in validation activities in facilities, commissioning, and system qualifications.
• Experience working within industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
• Experience with Biologics License Application (BLA) submissions etc.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
• Will work in environment operating a motor vehicle or Powered Industrial Truck.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishable color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time for up to 240 minutes.
• Ability to sit for prolonged periods of time for up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to operate machinery and/or power tools.
• Ability to conduct work that includes moving objects up to 50 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18'' to 60'' in height, and use twisting motions.
• Will work in warm/cold environments.
• Will work in outdoor elements such as precipitation and wind.
• Will work in small and/or enclosed spaces.
• Will work in heights greater than 4 feet.

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.

*LI-Onsite

EEO Information

Fujifilm is committed to 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 (View email address on hirelifescience.com).