QA Engineer, Drug Substance Manufacturing

Position Overview

The QA Engineer Drug Substance Manufacturing (DSM) Operations is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) 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. This role works 12-hour day shift on a 2-2-3 cadence 0600-1800.

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 70000 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: Description

What Youll 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.
• 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 Biotechnologies sites to streamline processes and maximize efficiency.
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
• Works 12-hour shift on 2-2-3 cadence 0600-1800.
• Performs other duties as assigned.

Knowledge Skills and Abilities

• 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.
• 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.
• Understanding of cell culture upstream processes large scale recovery and/or downstream processes.
• 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.
• Fully embraces a Genki culture able to bring positive energy to a dynamic work environment.
• Occasional opportunity for International and/or Domestic travel may be available.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• 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 with 1 years of applicable experience.
• 3 years of experience working in a GMP regulated environment.
• Experience in Validation cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.

Preferred Qualifications

• Working knowledge and experience with ASTM E2500 Smartsheet Trackwise MasterControl and/or Kneat validation software.
• Experience with startup projects or initiatives.
• Training and/or familiarity with Quality Risk Management principles preferred.

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 stand for prolonged periods of time for up to 30 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 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.

*LI -Onsite

EEO Information

Fujifilm is committedto 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 ().

Required Experience:

IC