Performs fractionation manufacturing operations at a senior level in an FDA licensed, cGMP controlled, high volume human plasma protein manufacturing plant. Works as part of a team, operating centrifuge and filtration separation equipment, controlling and monitoring the processes through computerized automation systems. Prepares chemicals, buffers, tanks, transfer lines and other equipment used in the plasma manufacturing process. Must work well in a team environment. Cleans, sanitizes and cares for equipment before and after use. Sanitizes processing areas. Follows manufacturing SOPs and completes batch records. Performs conductivity and in-process pH measurements and adjustments. Orders, maintains, and dispenses raw material inventories and records on disbursement sheets. Must be able to work shift schedules including weekends and overtime as required. Must be able to work a flexible schedule which will include nights, holidays and weekends. Typical shifts are 12 hours in duration. Relocation Assistance provided.
Good verbal and written communication skills. Ability to grasp mechanical, fluid flow and process parameter control concepts. Good math skills with knowledge of the metric system. Must be able to lift/push/pull heavy equipment. Mechanical aptitude and experience with CIP systems desired. Must be able to work in a cold (freezer) environment for part of the process. Computer skills are required. Experience with SAP or similar inventory tracking systems is a plus.
Minimum High School diploma or equivalent with some science courses. Bachelor's degree in chemistry or a life science preferred, but will consider equivalent work experience. Experience in a large scale manufacturing cGMP regulated environment working with Standard Operating Procedures and cGMP documentation practices is a plus. Preference will be given to candidates with plasma fractionation or purification experience.
Biotest Pharmaceuticals - 2 years ago