Production Technician – Downstream Processing

Job Description:

To produce veterinary biologics according to a defined production schedule following cGMP guidelines and specific outlines of production to meet market demands for Aquaculture products.

Duties/Responsibilities:

• Adhere to the principles of “Safety first, Quality always”
• Perform biologics recovery and purifications using process scale TFF unit, columns and chromatography system.
• Operate and maintain production instruments and equipment, such as pH meters, Conductivity meters, spectrophotometer, TFF equipment, Peristaltic pumps, rotary pumps, and chromatography systems
• Perform column packing using packing skids, integrity testing on various types of filters and process analysis using spectrophotometer
• Write and review batch records, SOPs, qualification documents for the downstream operations.
• Purchase raw material/production items and make required updates in SAP.
• Comply with safety requirements, cGMP, SOP, and manufacturing documentation.
• Collaborate with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in successful completion of projects.
• Work cross functional with the upstream manufacturing group to provide resources as needed.
• Perform tasks under minimal supervision, and within tight time lines to meet production schedules.
• Assist in the maintenance of production equipment in good condition as per manufacturer’s specifications
• Cleaning and sterilizing items used in  down streaming applications
• Maintain the cleanliness of the production areas and assist in disinfection procedures as needed

Minimum Qualifications:

• Bachelor’s degree or diploma; preferably Chemical Engineering, Biochemistry, or Chemistry.
• Process knowledge of TFF filtration and chromatography

Preferences for candidate:

• 1-3  years of pharmaceutical/biological manufacturing experience in GMP environment
• 1-3 years of experience in purification of biologics using large scale TFF and chromatography.
• Experience with operating Unicorn software
• Excellent computer software skills: MS Office (Word, Excel, Power Point), SAP and control systems.
• Excellent interpersonal skills, both communications and written. The candidate in this position must be able to communicate effectively with management and staff.

Job Requirements:

• Must be able to work shift work (12 hour daytime shifts, 3-4 days/week including some weekends) and overtime as required
• Required to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator.
• Must be able to lift, move and maneuver small-medium sized equipment – up to 25lbs.
• Requires ability to stand for long periods of time
• Requires frequent ladder or stair climbing
• Must be able to read, write, understand, and comply with appropriate standard operating procedures.