Position Overview

The Senior QA Engineer, Validation helps drive the Quality oversight for Commissioning, Qualification, and Validation (CQV) processes. The position also oversees, reviews, and approves QA validation activities and documents associated with decommissioning, new or modified systems as well as maintenance of the validated state of equipment, processes, and systems. Occasional opportunities for international and/or domestic travel may be available for this role.

Job Description

What You'll Do

• Serves as QA CQV subject matter expert (SME) with regulators, clients, and company management.
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure facilities, utilities and equipment are first validated and then maintained in a validated state.
• Oversees and approves system and process lifecycle documentation, including risk and impact assessments, user requirements, product, process, and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Develops, reviews, and approves QA procedures for the validation approach and lifecycle documents for facilities, utilities, and equipment.
• Ensures the completion of project and operational quality objectives within desired timelines.
• Provides manufacturing (Clean Room) shop floor support for issue resolution, as needed.
• Participates in optimization or improvement initiatives.
• Supports regulatory agencies and third-party inspections.
• Shares knowledge and mentors less experienced team members by providing technical guidance on QA validation activities.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Ability to work in a highly regulated environment, adhere to regulatory requirements, and follow Good Manufacturing Practices (GMP).
• Advanced ability to manage multiple assignments, meet deadlines, and balance competing priorities in a fast-paced GMP environment; excellent organization and critical thinking skills with ability to work independently.
• High-level understanding of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, Cleaning Development/Verification/Validation, and CQV methodologies.
• Ability to support SOP creation, program development, and training curricula to deliver operational and inspection readiness goals.
• Excellent communication skills, both written and oral to effectively collaborate cross-function and with department management.
• Extensive knowledge of Data Integrity and application of 21 CFR Part 820 and Part 11.
• Personal ownership, proactive partnerships, and knowledge management.
• Ability to fully embrace a Genki culture and bring positive energy to a dynamic work environment.
• Flexible to support a 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor's degree in Life Sciences or Engineering with 8+ years of applicable industry experience; OR,
• Master's degree in Life Sciences or Engineering with 6+ years of applicable industry experience; OR;
• PhD in Life Sciences or Engineering with 4+ years of applicable industry experience.
• 4+ years of experience working in a GMP regulated environment.
• Experience in Commissioning, Qualification, and Validation (CQV) and Quality oversight, in an FDA regulated facility.

Preferred Qualifications

• Working knowledge and experience with ASTM E2500, Smartsheets, Trackwise, Veeva, and Kneat validation software.
• High level of familiarity/understanding of Drug Substance, Drug Product, and/or Finished Goods manufacturing processes.
• Experience with complex projects.
• Experience with startup projects or initiatives.
• Training and/or familiarity with Quality Risk Management principles.

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:

• Ability to discern audible cues.
• Ability to stand for prolonged periods of time for up to 120 minutes.
• Ability to sit for prolonged periods of time for up to 120 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.

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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