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Senior Technical Writer
2 months ago
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