Manufacturing Technician II

LFB USA has an immediate need in our Manufacturing group for a Manufacturing Technician. Level will be based upon experience. Responsible for the commercial production of drug intermediates (protein purification, buffer/equipment preparation), intended for further manufacture of drug products. This is a senior technician position in a regulated biomanufacturing setting.

Strong emphasis is placed on adherence to Good Manufacturing Practices, and the importance of being in compliance with Standard Operating Procedures and Good Documentation Practices. More complex projects will be assigned on a case-by-case basis to support growth and development of employee.

• Independently operates & monitors production equipment, in accordance to procedures/batch records; including process tanks, balances, bioburden filtration assemblies, chromatography columns/skids, UF/DF equipment, data recorders and depth filter systems.

• Demonstrates strong practical/theoretical knowledge of biomanufacturing concepts and cGMP.

• Weights and measures raw materials, and prepares buffer solutions for use in bulk manufacturing.

• Performs equipment/sanitary parts CIP/COP (Clean In Place/Clean out of Place) and assists with production equipment maintenance, assembly and disassembly.

• Performs aseptic operations including equipment/in-process sampling and work in Laminar Flow Hoods/Biosafety Cabinets

• Disinfects/cleans cleanroom/facility and maintains plant consumable/inventory levels.

• Operates & standardizes analytical instruments including pH meters, conductivity meters, flow meters, spectrophotometers, integrity testers in accordance to Standard Operating Procedures (SOP's), with no supervision.

• Completes production records and documentation with strict adherence to Good Manufacturing Practices (cGMP's) and Good Documentation Practices. Maintains equipment logbooks, reviews & files documentation

• Assists in Validation/Engineering and Calibration activities.

• Practices safe work habits and adheres to company safety procedures and guidelines.

• Communicating process/documentation improvement opportunities, and executes projects with management oversight.

• Maintains "current" status on pertinent standard operating procedures including in training curriculum, via EQMS/documented training.

• Supports writing/development of standard operating procedures, and dept. non-compliance investigations (deviations), and execution of change controls. Trains/mentors and leads junior operators in absence of manager/supervisor.

• Works in cleanroom environment, and performs work duties in accordance to aseptic technique concepts/proper cleanroom (and gowning) protocol.

• Prepares facility/equipment and consumables based on established schedules.

• Executes facility inspection walkthroughs and communicates safety/contamination/repair issues/needs.

• Projects/development opportunities are provided based on employee development goals.

• Other duties as assigned.

The ideal candidate will have the following qualifications:

• High School Diploma (or GED) with a minimum of 3-4 years experience in a cGMP biologics manufacturing facility

• Associates Degree with 2-3 years experience in a cGMP biologics manufacturing facility

• Bachelor's Degree with a minimum of 1-3 years experience in a cGMP biologics manufacturing facility

• Ability to lift 50 lbs.

• Approved to wear a half mask respirator for short durations.

Work in a cleanroom environment for ~90% of day (full gowning).