Work Schedule: 12 hr shift/days
Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift
This candidate will be responsible for cleaning and sanitizing the manufacturing facility, cleaning of primary, secondary, and ancillary equipment, and assembly of production related manufacturing tanks, vessels, and supply assemblies in support of the manufacture of Commercial and Clinical Biologics. Additional activities consist of but are not limited to formulation of cleaning solutions, visual inspections of equipment and supplies and tools, operation of autoclaves, and operation of industrial washers in compliance with standard cGMP documented practices. This individual will be responsible for following Current Good Manufacturing Practices (cGMPs).
Execution of routine and non-routine cleaning of operational areas, per work instructions, and/or SOPs, with focus on "right the first time" executions.
Perform basic routine assembly and cleaning of manufacturing related equipment per work instructions and/or SOP's.
Follow daily production schedule.
Assist in all Department functions, such as maintaining supplies, equipment, logbooks, and data in accordance with site SOPs and policies.
Documentation of all activities to meet cGMP requirements. Complete logbook reviews and corrections. Daily logbook review, tasks, and databases. Actively provide feedback.
Participates in shift exchanges, 1-1's, meetings, attend meetings as needed to facilitate area needs based on changes, etc. (lean activities).
Support a quality investigation by answering questions, providing feedback, and making suggestions for improvement.
Practices and promotes safe work habits and adheres to safety procedures and guidelines.
HS Diploma/ GED required; 0 experience required.
Experience in manufacturing and/or GMP environment preferred.
Knowledge of cGMP practices, aseptic techniques, or chemical concepts- preferred
Strong math skills
Detail oriented.
Results Driven
MS Office
Able to read, write, and communicate in English.
Able to understand and carry out instructions.
Reliable
Effectively multi-task
Able to work in an environment of change.
Able to work independently and as part of a team.
Be willing to wear a full gowning suit which includes bodysuit, gloves, hair & beard nets, face covers, and safety glasses. (These items are prohibited: makeup, jewelry, nail polish, cologne / perfume, scented lotions, or hair care products, etc.)
Able to adhere to clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves.
Ability to lift minimum of 25 lbs. independently.
Ability to stand, walk, reach, stoop, kneel and/or crouch for 80% of the shift.