About The Position

Performs functions associated with cGMP manufacturing operations within a biologics production facility. The role includes working with engineers on setup and calibration tasks and performing rework and quality testing related to production parts, components, and final materials. Uses programs such as LIMS, SAP, and automated control systems to collect and evaluate operating data and make on-line adjustments to products, instruments, or equipment. Determines and may help develop methods and procedures to control or modify the manufacturing process. This position supports MD Fill aseptic gown operations. The specified B1 shift is 6:00 a.m. to 6:30 p.m. on Thursday, Friday, and Saturday, and every other Wednesday. The role requires wearing a full-body aseptic gown during an 8-hour shift and completing lot-cleaning sanitation during the work shift. Employees must follow cleanroom procedures, maintain aseptic technique, and complete required documentation accurately and on time.

Requirements

  • High school diploma or equivalent experience, with 2 or more years of experience; alternatively, an associate degree in science with 1 or more years of relevant experience; or a bachelor's degree with 0 or more years of relevant experience.
  • Acquire job skills and learn company policies and procedures to complete routine tasks.
  • Work on routine assignments requiring limited judgment.
  • Recognize when accepted practices are deviated from.
  • Follow detailed instructions for work.
  • Ability to wear a full-body aseptic gown during an 8-hour shift.
  • Willingness to complete lot-cleaning sanitation during the work shift.
  • Accurate and timely documentation; good handwriting is a plus.

Nice To Haves

  • Aseptic experience.
  • Aseptic PPE experience.

Responsibilities

  • Ship finished materials.
  • Maintain inventory levels.
  • Sample in-process and raw materials.
  • Operate the glass washer and autoclave.
  • Prepare buffers and media.
  • Prepare equipment using CIP/SIP.
  • Perform cell culture activities, from vial thaw through production scale.
  • Perform column chromatography.
  • Perform tangential flow filtration.
  • Wear a full-body aseptic gown during an 8-hour shift.
  • Complete lot-cleaning sanitation during the work shift.
  • Follow cleanroom entry and exit procedures.
  • Wear required aseptic gowning and PPE correctly at all times.
  • Perform hand hygiene and sanitization before entering the cleanroom.
  • Maintain aseptic technique to prevent contamination of materials and products.
  • Frequently and consistently sanitize work surfaces, tools, and equipment.
  • Minimize movement, talking, and unnecessary activity in the cleanroom.
  • Inspect gowning and PPE for proper fit and integrity before use.
  • Immediately report contamination concerns, spills, or equipment issues.
  • Handle sterile materials only in approved areas and in a controlled manner.
  • Follow environmental monitoring and cleaning requirements.
  • Dispose of waste and contaminated materials according to procedure.
  • Complete required documentation accurately and on time.

Benefits

  • Paid time off, including vacation, holidays, and sick time.
  • Medical, dental, and vision insurance for eligible employees.
  • 401(k) for eligible employees.
  • Eligibility to participate in short-term incentive programs.
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