Engineer, QA Drug Substance Manufacturing

NCBiotech; Holly Springs (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking an Engineer, QA Drug Substance Manufacturing to drive quality oversight from development through startup to commercial operation. You will validate processes and oversee lifecycle documentation, risk assessments, and QA support for manufacturing in a cGMP facility.

Minimum qualifications include a BS/BA with 5+ years in GMP environments, or MS with 3+ years, or PhD with 1+ year. Travel and 24/7 support flexibility may be required.

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.

Responsibilities

• 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 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.

Skills

QA oversight

GMP knowledge

FDA regulations

Validation

Documentation

Education

BS/BA Life Sciences or Engineering

MS Life Sciences or Engineering

PhD Life Sciences or Engineering

Tools

Smartsheet

Trackwise

MasterControl

Kneat

ASTM E2500

Job description

Position Overview

The Engineer, QA Drug Substance Manufacturing 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.

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 drive-what 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." 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 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.

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.

Physical Requirements

• Ability to discern audible cues.
• 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 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.

*LI-Onsite

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 ([e-mail]).