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Senior Technical Writer

2 months ago

Libertyville, United States Integrated Resources, Inc ( IRI ) Full time

Job Title: MSAT Technical Writer

Job Location: Libertyville, IL- Hybrid Role

Job Shift : 6 months+


Job Description: MSAT Technical Writer, Cell Therapy Vector Support ,Support, Manufacturing Science and Technology (MSAT)


The focus of the MSAT Technical Writer is to investigate and write root cause analyses for non-conformance events during the manufacturing of cell therapy vector.. The MSAT Tech Writer:

- Compiles and interprets manufacturing process data to identify possible failure modes

- Learns complex cell biology concepts & applies them to root cause investigations

- Works independently and with Process Engineer(s) to understand different failure modes

- Works with GMP Quality Systems to deliver completed Root Cause Analysis investigation reports


Education:

- BS in Bio/Chem Science/Engineering or related field

- Immunology education preferred


Experience:

Required experience:

• 3+ years relevant experience in drug product biopharmaceutical or equivalent industry

• Deviation writing

• cGMP/cGDP

• Ability to prioritize multiple investigations in order to meet deadlines

• Strong scientific and technical acumen including technical writing skills


Preferred experience:

• Quality management system

• Complex problem-solving skills, including root cause investigation

• Cross-functional collaboration with engineering and quality partners

• Biologics or cell therapy manufacturing

• Trained in Kepner Tregoe Problem Solving


Duties and Responsibilities:

• Facilitates deviation closure through working with quality partners and site quality systems

• Analyzes and summarizes manufacturing data to support root cause investigations

• Analyzes and summarizes characterization data to write root cause investigations

• Utilizes root cause analysis tools such as fishbone, 6Ms, Five Whys, to identify root cause

• Writes technical and thorough investigation reports

Responsibilities

  • Explain technical ideas in simple language
  • Meet with customer representatives to establish technical specifications
  • Create user documentation for a variety of material


Qualifications


  • Bachelor's degree or equivalent experience
  • Experience in the technology industry
  • Strong written and verbal communication skills
  • Ability to understand highly technical information