Job Title: Technical writer

Location: Libertyville, IL (Hybrid)

Type: Contract

Responsibilities

• 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

• 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

  Requirements

  Education:

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

• Immunology education preferred

  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

  Benefits

  System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.