Manufacturing Associate III (Purification - Large Scale Manufacturing)
Professional Diversity Network
Research Triangle Park, Durham, NC, USA
The Manufacturing Associate performs and documents daily manufacturing operations in a cGMP environment that involves operation of process equipment, execution of validation protocols, creating/ revising cGMP documents and other assignments. The incumbent is highly detailed oriented with excellent documentation skills. The incumbent will become trained and skilled at most or all unit operations in their area, often leading the execution of procedures, and performs most functions with minimal supervision.
Major Responsibilities include but are not limited to:
Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record and control system. May coordinate or lead process steps as requested
Documents/Records and Reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Revises or creates documents as instructed. Key documentation includes batch records, SLRs, and equipment logbooks.
Actively participates in training activities, managing their individual training plan. Trains other associates as required.
Executes validation protocols with minimal supervision/direction of others.
High School Diploma or equivalent in addition to at least 1-2 years of relevant industry experience (Bachelor's Degree preferred)
Targeted biopharmaceutical training (Bioworks or equivalent) and/or related military training preferred
Detailed oriented with excellent documentation skills
Operates in a safe manner in order to avoid injury to self and others
Strong peer and team leadership skills.
Adaptable to changing needs and demands, comfortable navigating in a changing environment
Comfortable with ambiguity; quickly understands the needs based on the situation at hand
Influencing and leading a positive attitude throughout team
Ability to communicate clearly and effectively to all levels of the organization
Ability to interact with others in a professional and courteous manner in accordance with Biogen's Core Behaviors
Capable to work a 12-hour shift, both day shift or night shift
All your information will be kept confidential according to EEO guidelines.