FUJIFILM Biotechnologies
QA Engineer, DSM (Project QA)
FUJIFILM Biotechnologies - Holly Springs, North Carolina, United States, 27540
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Overview
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QA Engineer, DSM (Project QA)
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QA Engineer, DSM (Project QA)
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FUJIFILM Biotechnologies The QA Engineer, DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during project phase through to operational readiness. The QA Engineer, DSM is responsible for quality assurance oversight of day?to?day activities and resolution or mitigation of issues.
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
Were 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 were proud to cultivate a culture that will fuel your purpose, energy, and drivewhat we call Genki. Ready to shape the future of medicine? Lets transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleighs 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: https://www.fujifilm.com/us/en/about/region/careers
Job Description
What You'll Do
Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM 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
Minimum Requirements
BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR MS in Life Sciences or Engineering and 3+ years of applicable experience OR PhD in Life Sciences or Engineering and 1+ years of applicable experience 3+ years of experience in a GMP environment Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies
Preferred Requirements
Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software Experience with startup projects or initiatives
Working & Physical Conditions
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands 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.
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 (FDBN_PNC@fujifilm.com).
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QA Engineer, DSM (Project QA)
role at
FUJIFILM Biotechnologies Continue with Google Continue with Google 3 days ago Be among the first 25 applicants Join to apply for the
QA Engineer, DSM (Project QA)
role at
FUJIFILM Biotechnologies The QA Engineer, DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during project phase through to operational readiness. The QA Engineer, DSM is responsible for quality assurance oversight of day?to?day activities and resolution or mitigation of issues.
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
Were 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 were proud to cultivate a culture that will fuel your purpose, energy, and drivewhat we call Genki. Ready to shape the future of medicine? Lets transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleighs 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: https://www.fujifilm.com/us/en/about/region/careers
Job Description
What You'll Do
Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM 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
Minimum Requirements
BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR MS in Life Sciences or Engineering and 3+ years of applicable experience OR PhD in Life Sciences or Engineering and 1+ years of applicable experience 3+ years of experience in a GMP environment Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies
Preferred Requirements
Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software Experience with startup projects or initiatives
Working & Physical Conditions
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands 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.
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 (FDBN_PNC@fujifilm.com).
Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Engineering and Information Technology Referrals increase your chances of interviewing at FUJIFILM Biotechnologies by 2x Sign in to set job alerts for Quality Assurance Engineer roles.
Continue with Google Continue with Google Continue with Google Continue with Google Software Test (Manual) Engineer (Medical Device Industry)
Durham, NC $95,000.00 - $105,000.00 1 day ago Raleigh, NC $85,000.00 - $110,000.00 3 days ago Sr. Engineer, QA Operations (Tech Transfer)
Sr. Engineer, QA Operations (Tech Transfer)
Technology Quality Assurance Analyst II (Hybrid - Raleigh, NC)
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Technology Quality Assurance Analyst III (Hybrid - NC)
Technology Quality Assurance Analyst III (Hybrid - Raleigh, NC)
Technology Quality Assurance Analyst III (Hybrid - Raleigh, NC)
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr