Technical Writer

Job Details

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 is 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.
• 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.

 Cynet Systems

 05/11/2024

 Libertyville,IL