RBC Processing Technologist

Overview

We are currently seeking a RBC Processing Technologist to join our Red Blood Cell Processing team. As a RBC Processing Technician, you will perform a variety of activities in the Red Cell Processing Department. Processes red blood cells, formulates red blood cell products into a diluted (bulk) state, and performs in-process testing in an aseptic production environment. Performs production tasks in a cleanroom environment in compliance with Good Manufacturing Practices and Good Documentation Practices.

This position is not eligible for sponsorship for work authorization.

• Performs blood processing operations according to corporate policies, operating procedures, specifications, and work instructions.
• Ensures blood products are transported, processed, and stored in a manner that prevents contamination.
• Follows appropriate control measures to prevent mixing of dissimilar production components in compliance with Good Manufacturing Practices.
• Performs in-process testing and visual inspections of product for defects.
• Creates legible written processing records that initiate product Batch Records and comply with all procedures and Good Documentation Practices.
• Follows applicable laboratory & OSHA regulations with respect to hazards and blood-borne pathogens.
• Maintains a neat, clean, and orderly work environment.
• Independently performs equipment setup, operation, re-supply, documentation, cleaning, minor adjustments and minor maintenance tasks to meet standards for safety, quality, reliability, and efficiency.
• Applies FDA regulations, and ISO standards to department operations and understands consequences of non-conformance.
• Moves, stores, and inventories production supplies and materials according to department specifications.
• Completes all training and qualification requirements; actively participates in on‑going training and the training of new employees.
• Assist and communicate with co‑workers to assure all safety, quality, and efficiency objectives are achieved.
• Demonstrate supportive behaviors towards co‑workers and cooperate as a member of the team.
• Demonstrate behaviors supportive of personal and professional growth of self and co‑workers.
• May perform BAAN entries (Production Orders, Material Transfers, BOMs) and data entry support, as needed.
• May support and perform review of Manufacturing DHRs for RBC Processing, Solid Phase, VLP, Serum Bulk Manufacturing, and cleaning and maintenance records as needed.
• Performs other duties as assigned by RBC Processing Management.

• Bachelors of Science degree in Biological (or related sciences) required, or Bachelor’s degree with at least 3 years related laboratory experience required.
• Preferred Experience:
  
  >1 year in GMP cleanroom environment.
• Must be able to accommodate production requirements that may require 50+ hour workweeks, including extended day hours and weekends.
• Experience working in an aseptic environment, preferred.
• Must be able to complete courses and/or assessments related to aseptic technique and gowning. The employee must then be able to work while aseptically gowned in a clean room environment.
• The employee must maintain their personnel environmental monitoring results within specifications.
• Available for temporary assignment to other areas for skills development or to support company needs.
• Must be able to work irregular hours and days as necessary to meet production schedules.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume.
• Using hands to manipulate product. Lifting, pushing or pulling various amounts of weight are required.
• Overhead storage may require reaching for product/supplies.
• Ability to stand over intervals of several hours at a time.
• Ability to check for defects, test readings, identifies and distinguish between colors to verify results.
• The majority of the work day may be spent standing. Bending, squatting and reaching are also required.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact N for assistance.