Compounding Technician II (3rd Shift)

American Regent, Inc.•Hilliard, OH

About The Position

The Compounding Technician II is a member of the Manufacturing Team, which manufactures safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The team maintains aseptic and sanitary conditions where required, keeps manufacturing area and equipment records accurate, and supports production schedules and company goals in coordination with Production Management. The Team Member participates in all aspects of the compounding process, including dispensing raw materials, compounding, sterile filtration, controlling and using chemical raw materials according to batch directions, performing in-process quality-control sampling and testing, cleaning and sterilizing equipment, and completing equipment tear-downs and line clearances. Work is performed according to established production records and company SOPs. The Technician is expected to become proficient in compounding activities and work with minimal supervision, receiving direction, training, and mentorship from Senior Compounding Technicians. The role also supports equipment setup and troubleshooting, supply and equipment staging, documentation review, and employee training. The position requires working with chemicals and wearing cleanroom and protective equipment; employees must meet applicable sterile-compounding certification, gowning, and respirator-fit requirements.

Requirements

High school diploma or GED equivalent.
At least one year as a Compounding Technician I with satisfactory performance, or three years of similar work experience in a related field; listed as preferred in the posting.
Ability to work in an environment where chemicals are handled and dispensed daily.
Excellent chemical-handling and mathematical aptitude, with the ability to assemble, troubleshoot, and perform minor repairs on manufacturing equipment.
Ability to meet and maintain Class 100 Certification for sterile compounding/transfer at the Hilliard facility, and to maintain cleanroom gowning and respirator fit-testing requirements.
Ability to accept feedback constructively and work in a team-oriented environment.
Ability to read Standard English documents, including SOPs, maintenance schedules, and operating manuals.
Ability to work overtime as needed.
Ability to wear cleanroom and protective equipment, including gowning, goggles, face shields, respirators, and protective gloves.
Must maintain a clean-shaven appearance each working shift to properly wear tight-fitting respirators.
Ability to occasionally lift and/or move up to 50 pounds.

Nice To Haves

Associate or bachelor’s degree in chemistry or another science field.
Experience with manufacturing technology such as HMI-PLC/SCADA-controlled isolation barriers, autoclave sterilization, CIP sanitization, and SIP sterilization.

Responsibilities

Perform all activities associated with the compounding process, working with minimal supervision and receiving direction, training, and mentorship from Senior Compounding Technicians.
With assistance from senior team members, troubleshoot minor equipment adjustments, diagnostics, and repairs during setup and operation.
Use scales, balances, and load cells to weigh materials and perform batch additions; use blending, mixing, and other homogenization technologies.
Set up aseptic filtration, perform filter integrity testing, and complete mass and concentration calculations to determine batch dosing based on material potency.
Stock, gather, and stage manufacturing supplies and equipment; assist team members with equipment assembly and cleaning.
Perform compounding activities and related tests, including daily performance verifications, pH measurements, dissolved-oxygen testing, and filter testing.
Use only approved documentation and procedures.
Oversee production supplies and materials as needed.
Clean and store equipment and support equipment gathering, staging, area cleaning, and operating-supply inventory control.
Attend required training programs and assist in training new employees on compounding, raw-material dispensing, and equipment-cleaning procedures.
Dispense raw materials using balances or scales inside and outside the Formulation Isolator, and directly charge materials into the vessel in accordance with SOPs.
Review logbooks and batch documentation for accuracy during execution on the floor.
Act as the Lead in the Lead’s absence.
Perform other tasks and duties assigned by management.