Quality Assurance Operations Engineer

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.  

 

The Quality Assurance Operations Engineer is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes through to operational readiness during project phase. This role is responsible for quality assurance oversight of day‐to‐day activities and resolution or mitigation of issues.

External US

MAJOR ACTIVITIES AND RESPONSIBILITIES:

 

• Performs an SME role within the QA team for the development of documents, processes, and procedures for the validation program.
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Ensures project and operational quality objectives are met within desired timelines.
• Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency.
• Participates in optimization or improvement initiatives and support regulatory agency and third‐party inspections.
• Performs other duties as assigned.

 

BACKGROUND REQUIREMENTS:

 

• BS/BA in Life Sciences or Engineering or equivalent with 6+ years of applicable industry experience OR
• MS in Life Sciences or Engineering and 4+ years of applicable experience OR
• PhD in Life Sciences or Engineering and without any experience years of applicable experience
• 3+ years of experience in GMP Quality Assurance and/or similar role
• Multiple years of experience, with increasing levels of responsibility and accountability, in Validation, cGMP manufacturing operations, and/or Quality oversight in an FDA regulated facility
• High level of familiarity/understanding of validation of production equipment, clean utilities, quality systems, automation, cleaning validation, manufacturing or IT systems.  
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11
• Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
• Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes
• Experience with startup projects or initiatives.
• Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.

Desired Skills:

• Strong verbal and written communication skills to partner with different teams and stakeholders
• Excellent oral and written communications skills and fluency in English
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Ability to think critically and have superior problem‐solving skills.
• Team based attitude and ability to build relationships and communicate effectively with others.
• Collaborative attitude with the willingness to work with global peers and cross‐functional teams toward company and department goals.
• Basic knowledge and application of cGMP compliance and other related regulations

 

 

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 l