Manufacturing Operations Support Specialist

2 weeks ago

Holly Springs, United States FUJIFILM Holdings America Corporation Full time
Overview

Join a Leading Life Science Manufacturing Organization

At FUJIFILM Holdings America Corporation, we are committed to making a significant impact in the life sciences sector. We are on the lookout for dedicated individuals who are eager to contribute to the advancement of healthcare solutions. Our mission is to manufacture innovative therapies and vaccines in collaboration with top-tier biopharmaceutical companies worldwide.

About This Role

This position involves supporting manufacturing processes related to drug products and finished goods, ensuring that production is compliant and dependable. Our facility operates around the clock, and flexibility in working hours may be required.

Key Responsibilities

  • Lead operational readiness initiatives during project phases, including site commissioning and qualification.
  • Assist in troubleshooting within specific process areas.
  • Update documentation to ensure reliable production processes.
  • Create non-batch activities and relevant documentation for technical transfers, changeovers, and preventive maintenance plans.
  • Support change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement initiatives.
  • Facilitate inspections and audits by providing necessary manufacturing documentation.
  • Perform additional duties as assigned.

Who You Are

You will engage in manufacturing support activities to guarantee compliance and reliability in production. Your role will involve managing documentation updates, supporting investigations, and contributing to corrective actions.

Basic Qualifications

  • High School Diploma or GED with four years of relevant experience.
  • Excellent verbal and written communication skills.
  • Strong time management abilities.
  • Adaptability in a fast-paced environment, with the capability to adjust plans as necessary.
  • Critical thinking and superior problem-solving skills.
  • A collaborative mindset with the ability to work effectively in a global team setting.
  • Proficiency in updating and creating documents according to schedules.

Preferred Qualifications

  • Associate degree in life sciences with two years of direct experience, or
  • Bachelor's degree in life sciences with no prior experience, or
  • Equivalent military experience.
  • Experience in manufacturing operations.
  • Familiarity with change management, investigations, CAPAs, and continuous improvement processes.
  • Completion of BioWorks or BTEC Capstone cGMP coursework is preferred.

Working Conditions & Physical Requirements

  • May require respiratory protection in certain environments.
  • Potential exposure to mechanical or production spaces necessitating hearing protection.
  • Ability to operate a motor vehicle or powered industrial truck.
  • Capability to discern audible cues and perform tasks requiring visual acuity.
  • Physical stamina to stand or sit for extended periods and conduct repetitive motions.
  • Ability to lift and move objects as needed.

FUJIFILM Holdings America Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.

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