FUJIFILM
QA Engineer, DSM Operations - Nights
FUJIFILM, Holly Springs, North Carolina, United States, 27540
Position Overview
The QA Engineer, DSM Operations (Night) is responsible for driving the Quality oversight for the direction of all Drug Substance Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation. 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 drivewhat 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." Job Description
What You'll Do Perform an SME role within the QA team for the development of documents, processes, and procedures for the DSM program (Working Schedule: 1800-0600 in a 2-2-3 cadence) Per applicable procedures, provides QA support of tasks such as BPR review, event triage, DR/CAPA review and approval, area changeover and release and WO oversight 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 documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility Ensures operational quality objectives are met within desired timelines Participates in optimization or improvement initiatives Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency Perform other duties as assigned Minimum 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 3+ years of experience in GMP Quality Assurance and/or similar role 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 Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11 Preferred Requirements: 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 Occasional opportunity for International and/or Domestic travel may be available Training and/or familiarity with Quality Risk Management principles Physical and Work Environment Requirements: Ability to discern audible cues. Ability to stand for prolonged periods of time up to 30 minutes Ability to sit for prolonged periods of time up to 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. Will work in warm/cold environments Will work in small and/or enclosed spaces. 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).
The QA Engineer, DSM Operations (Night) is responsible for driving the Quality oversight for the direction of all Drug Substance Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation. 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 drivewhat 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." Job Description
What You'll Do Perform an SME role within the QA team for the development of documents, processes, and procedures for the DSM program (Working Schedule: 1800-0600 in a 2-2-3 cadence) Per applicable procedures, provides QA support of tasks such as BPR review, event triage, DR/CAPA review and approval, area changeover and release and WO oversight 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 documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility Ensures operational quality objectives are met within desired timelines Participates in optimization or improvement initiatives Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency Perform other duties as assigned Minimum 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 3+ years of experience in GMP Quality Assurance and/or similar role 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 Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11 Preferred Requirements: 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 Occasional opportunity for International and/or Domestic travel may be available Training and/or familiarity with Quality Risk Management principles Physical and Work Environment Requirements: Ability to discern audible cues. Ability to stand for prolonged periods of time up to 30 minutes Ability to sit for prolonged periods of time up to 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. Will work in warm/cold environments Will work in small and/or enclosed spaces. 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).