LSNE - Madison, LLC
  • Madison, WI, USA
  • Full Time

JOB SUMMARY -

This position is responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMP/ISO requirement and standards. With general supervision, the individual will perform routine and critical manufacturing operations, including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, aseptic compounding, filling and packaging activities for biopharma and medical device products. Work with Master production records, standard operating procedures, and device records.

JOB DUTIES -

  • Maintain and adhere to safe work habits and all applicable LSNE safety procedures and guidelines
  • Assembles, disassembles and operates aseptic filling equipment and lyophilizer equipment in classed cleanroom and controlled non classified environments
  • Prepare equipment and components for sterilization and Lyophilization
  • Operate processing equipment including autoclaves, ovens, vial washers, and depyrogenation, centrifuges, mills equipment. Perform clean-in-place and sterilization-in-place of tanks
  • Preparation of solutions, aseptic filling and labeling of vials under sterile and non-sterile conditions, routine solution and filtration, vial and component preparation and sterilization
  • Assists in the formulation and dispensing of product in a clean room environment
  • Wash equipment and stoppers, vessels, vials, etc.
  • Sanitize production areas and prepare equipment for production
  • Clean (manually and clean-in-place) and assemble equipment for production
  • Operates vial capper, unloads product from lyophilizers and liquid fill line
  • Perform dissolution, formulation and sterile filtration of products per SOPs and MBRs
  • Complete and maintain documentation related to assigned work, including logbooks, batch records, etc.
  • Strong adherence to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
  • Identifies, escalates and documents events that deviate from normal operation; participate as needed in investigations
  • Maintain compliance, cleanliness and orderliness of operational areas per appropriate SOPs
  • Perform COP, CIP, and SIP operations to prepare equipment for manufacturing operations
  • Review and revise pertinent SOPs and production batch records as required
  • Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment
  • Ability to weigh and measure raw materials and operate basic Benchtop instruments
  • Strong commitment to conducting LSNE business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of LSNE products and services
  • Honesty, integrity, respect and courtesy with leadership and peers
  • Inspire and constantly strive to make LSNE a great place to work and respected for the quality of its people and products and clients

EDUCATION, PROFESSIONAL SKILLS, EXPERIENCE -

  • Requires AA degree with 0-2 years' experience or high school diploma with 1-3 years related manufacturing experience or Associates Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Biotech Certificate and 1 year of experience
  • B.S. in a Scientific discipline - Biology, Chemistry or Biotechnology preferred with 1-3 years of Cleanroom, Biotech, Medical Device, Pharma experience
  • Must be able to perform basic math skills (multiplication, division, ratios, and percentages)
  • Microsoft Office (Excel and Word) experience Excellent communication and organizational skills.Attention to detail with strong mechanical aptitude are positivesThe ability to execute against SOP's and document entries in a cGMP compliant mannerPositive attitude and strong interpersonal skills. Excellent organizational skills and prioritizingStrong knowledge of aseptic techniques preferred. Experience in reviewing and creating controlled documents

PHYSICAL REQUIREMENTS

  • Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
  • Ability to gown and gain entry to controlled manufacturing areas
  • Ability to lift, pull or push equipment requiring up to 25-50 lbs of force
  • Ability to stand for 6 hours in a production suite

COMMUNICATIONS & CONTACTS

  • Interacts with cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc.

MANAGERIAL & SUPERVISORY RESPONSIBILITIES Not Applicable

LSNE - Madison, LLC
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