Requirements
- Bachelor’s degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) preferred, with a minimum of 2 years relevant experience in biopharmaceutical manufacturing also preferred.
- Associate degree in a technical field and a minimum of 3 years of relevant experience in biopharmaceutical manufacturing.
- High school diploma or equivalent and a minimum 4 years of relevant experience in biopharmaceutical manufacturing.
- At least 2 years of experience in a GxP regulated environment, with a focus on batch record review, batch disposition, Shop Floor QA, Manufacturing Quality Assurance, and/or Incoming Quality Assurance.
- Proficient in MS Office Suite.
- Proficient in using an Electronic Document Management System for documentation, workflow management, and compliance tracking.
Nice to Have
- Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus.
Work Arrangement
On-site
Additional Information
- Ability to stand for 3 or more hours while on the shop floor.
- Ability to work a 2-2-3 schedule where each shift is 12 hours in length. During construction and commissioning, this position will follow a Monday–Friday day shift schedule. Once the facility is operational, the role will transition to a 2-2-3 day shift (7:00 AM – 7:00 PM). Shift flexibility may be required during production runs.
- Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.
