QA Technical Specialist, Validation

Overview

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines.  We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.  

We are seeking a highly motivated individual to function as a Quality Assurance SME, with limited supervision, in our Contract Manufacturing site located in Research Triangle Park, NC.  Primary responsibilities will be to support the QA Systems team responsible for monitoring Deviations, CAPAs, and Change Controls/management, performance of external audits/site inspections and readiness activities.  Successful candidate will have specialization in validation and a proven track record of leading teams and collaborating cross-functionally.  Experience with change management review boards is a plus.

External US

MAJOR ACTIVITIES AND RESPONSIBILITIES:

 

• Provide Quality technical expertise, Quality oversight, and be a single point of Quality contact for commissioning, qualification, and Validation related activities, to include equipment and instrument qualification, cleaning validation, and/or computer software validation. 
• Site Quality Engineering SME for local validation deliverables to the QA validation team and cross-functional system owners and support the change control process for validated systems.
• Support the cross-functional system owners with strategic quality oversight and input with validation deliverables.
• Guides and demonstrates compliance with agency regulations/guidance and standard operating procedures regarding new system implementation, validation planning and deliverables, and risk management.
• May work with high-risk investigations to document Quality Issues and resolutions to ensure proper and robust actions are taken to eliminate re-occurrence.
• Participate in third party (Notified Body, FDA, Customer) audits as required.
• Provide continued quality system support by improving processes and systems and by updating and creating site procedures.
• Escalate Quality issues to upper management based on risk, trend, and compliance assessment.
• Ability to work independently, handle multiple tasks simultaneously and to meet critical milestones and goals.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Contributes to continuous process improvement efforts to improve efficiency and quality culture reinforcement.

 

BACKGROUND REQUIREMENTS:

• Bachelor’s Degree (or U.S. equivalent) in Validation Engineering, Pharmaceutical Chemistry, Chemistry or Pharmaceutical Sciences plus 5 years of experience in Quality Assurance and Validation of equipment, facility, cleaning, and/or computer software in the biotech or pharmaceutical industry.
• Strong knowledge of regulatory requirements (21 CFR Part 11/210/211, ICH Q8, ICH Q9, ICH Q10) as it relates to validation.
• Proven strength in one or more of the following validation principles:  equipment, instrumentation, facilities and utilities, cleaning, or software.
• Demonstrates in-depth knowledge of quality engineering principles, concepts, industry practices, and standards.
• Certification by ASQ (Certified Quality Engineer or Certified Quality Manager) or other industry recognized professional organizations is preferred.
• Proven competence to evaluate, communicate, and act upon significant risks, demonstrating leadership of the high standards of quality and compliance.
• Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources.
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership.
• Demonstrated track record of applying scientific, technical knowledge and problem-solving approaches to deliver business results.

 

 

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R.