Engineer, QA Drug Substance Manufacturing

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina seeks an Engineer, QA Drug Substance Manufacturing to lead quality oversight for DSM processes from development through startup to commercial operation.

You will participate in validation, change management, and regulatory inspections, collaborating across global teams to ensure cGMP compliance and operational readiness.

Qualifications

• BS/BA in Life Sciences or Engineering with 5+ years of industry experience, or higher degrees with fewer years.
• 3+ years of GMP regulated experience, with validation or quality oversight.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.
• Knowledge of risk management principles and regulatory expectations.
• Excellent communication and collaboration across global teams.
• Familiarity with data integrity, 21 CFR Part 11, and regulatory inspections.

Responsibilities

• Performs SME role within the QA team for the DSM program documents, processes, and procedures.
• Oversees impact assessment of system and process modifications and change management to keep Manufacturing Systems validated.
• Provides oversight and approval of lifecycle documentation including risk assessments, specs, and validation plans.
• Generates, reviews, and approves QA procedures for validation approaches and lifecycle documents.
• Generates and approves QA documentation and processes for operational readiness in a cGMP facility.
• Ensures project and operational quality objectives are met within timelines.
• Collaborates with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
• Supports regulatory agency and third-party inspections.

Skills

QA Oversight

Change Management

Validation

Documentation

GxP Compliance

Data Integrity

21 CFR Part 11

GAMP5

Cross-functional

Education

BS/BA Life Sciences or Engineering

MS Life Sciences or Engineering

PhD Life Sciences or Engineering

GMP Experience

Tools

Smartsheet

TrackWise

MasterControl

Kneat

Job description

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.

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.