Manufacturing Associate 2 (Downstream) - Day Shift (2-2-3)

Manufacturing Associate 2

Help us deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 2 to execute and document manufacturing processing activities in a cGMP environment. You will support both project-phase readiness (procedures, process transfer, testing/commissioning) and steady-state operations in a 24/7 facilityhelping ensure safe, consistent, and efficient production of drug substance.

Job Description

What You'll Do

• Contribute to project-phase operational readiness for bulk drug substance manufacturing.
• Support procedure review/creation and development or transfer of manufacturing business processes.
• Provide testing and commissioning support for equipment/systems; travel up to 025% (domestic or international) may be required.
• Execute and document manufacturing processing steps and support activities; perform process monitoring and control per cGMP standards.
• Perform in?process testing (e.g., pH, conductivity, visual inspection).
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs).
• Maintain required training and qualifications for all assigned activities.
• Work assigned shifts in a 24/7 operation, including weekends and potential nights.
• Perform other duties as assigned.

Minimum Qualifications

• High School Diploma or GED and 2 years of related experience (or equivalent combination of education and experience).
• 2+ years of direct experience in a cGMP manufacturing environment.
• Knowledge of support process equipment and understanding of cGMPs, safety, and operational procedures.
• Ability to follow technical instructions, perform operations, and document accurately.
• Strong verbal and written communication; ability to work effectively in a team.
• Ability to adapt in a fast?paced, changing environment.
• Willingness to work shifts (including weekends/nights) and travel up to 025% as needed.

Preferred Qualifications

• Associate degree, preferably in Life Sciences or a related field.
• Qualified in a support area (e.g., Formulation Buffer Prep, Media Prep, or DSM Buffer Prep) through internal or post?hire training.
• BioWorks or BTEC Capstone cGMP coursework.

Physical Requirements

The physical demands described here are representative of those that may be required to successfully perform essential job functions in a manufacturing environment. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Requirements may include:

• Standing and/or sitting for prolonged periods.
• Performing repetitive motions involving wrists, hands, and fingers.
• Working in proximity to production equipment and utilities.
• Lifting or moving materials as required by task?specific SOPs and safety guidelines.

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 (View email address on click.appcast.io).