Manufacturing Operations Specialist
4 days ago
Fladger Assoc. Inc. is seeking a skilled Manufacturing Technician to join our team in Frederick, MD. This is a contract opportunity with a duration of 12-36 months, offering a negotiable rate.
Responsibilities:
We are looking for an experienced professional to operate upstream/downstream/central services processing equipment according to established SOPs. This includes bioreactors, TFF skids, biological safety cabinets, incubators, chromatography skids, UFDF skids, autoclaves, washers, and product hold tanks. The successful candidate will also be responsible for upstream/downstream/central services processing according to established manufacturing production records (MPRs & SPRs) in accordance with cGMPs. Additionally, they will provide training on these activities and be able to operate process equipment with intent to be qualified. Revise cGMP documentation as needed.
Requirements:
We require 0-1 years of experience with a Bachelor's degree, 1-2 years of experience with an Associate's degree, or 3-5 years of experience with a High School diploma. A BS/BA degree is preferred, but Associates Degree and High School Diploma are acceptable with experience. The ideal candidate should have a complete acquaintance with and understanding of the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered. They should also have advanced knowledge of cGMP standards, basic equipment knowledge to perform first-line trouble shooting and root cause analysis, and ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations is also required. Good organizational skills and situational self-leadership are essential.
Work Schedule:
This position requires working a night shift from 6pm to 6am on a 2-2-3 schedule (2 days on, 2 days off, 3 days on).
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