Aseptic Filling Technician — Cleanroom Specialist (1st Shift)

FUJIFILM Biosciences; Warminster Township (Bucks County); On-site; USD 32,000 - 36,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences is hiring an Aseptic Filling Technician to prepare and operate aseptic filling equipment in a cleanroom, ensuring cgMP compliance. The role requires a hands-on background in sterile product manufacturing and strong attention to documentation and SOP adherence. First shift hours are 8:00 am to 5:00 pm, stationed in the U.S.

Bucks County area. The team emphasizes quality, safety, and precise vialing of final products.

Qualifications

• Associate degree or equivalent.
• 1–2 years aseptic filling experience.
• Experience in manufacturing sterile products.
• Ability to read and understand SOPs and documentation.

Responsibilities

• Prepare and set-up aseptic filling/filtration equipment in a cleanroom.
• Follow aseptic-filling procedures with manual or automated systems.
• Adhere to cleanroom gowning and behavior protocols.
• Disinfect controlled areas in compliance with SOP.
• Perform room/station set up and batch set up.
• Maintain accurate and complete documentation.
• Document vialing in batch records and use electronic systems.
• Manage components and supplies to keep inventory accurate.
• Follow line clearance to maintain cgMP and cGLP.
• Wear PPE and follow safety procedures.
• Clean room and equipment per procedures; apply 6S.
• Ensure supplies are stocked and request replenishment as needed.
• Complete filter integrity testing timely.
• Complete filling documentation timely.
• Suggest SOP improvements and other duties as assigned.

Skills

Aseptic filling experience

Life science product inspection

Analytical balances operation

Pipetting techniques

cGMP/GLP knowledge

English literacy (read/write)

Education

Associate degree or equivalent

Job description

FUJIFILM Biosciences is hiring an Aseptic Filling Technician to prepare and operate aseptic filling equipment in a cleanroom, ensuring cgMP compliance. The role requires a hands-on background in sterile product manufacturing and strong attention to documentation and SOP adherence. First shift hours are 8:00 am to 5:00 pm, stationed in the U.S.

Bucks County area. The team emphasizes quality, safety, and precise vialing of final products.