Manufacturing Associate

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manufacturing Associate II working on the Biologics Manufacturing team, you will be empowered to use your GMP experience to improve process operations, and a typical day will include: The Manufacturing Associate II performs and documents cGMP activities to support upstream and downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed. He or she may be responsible for training less experienced or new manufacturing associates. Position Accountabilities Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record, SLR and control system. Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records, SLRs, and equipment logbooks. Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMP s Performs the weighing, dispensing of raw materials for media and buffers Performs the preparation of small and large volume media and buffer solutions, filtration and transfer of product Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc. Dispensing, labeling, transfer/staging of raw materials and parts Assembly/disassembly, cleaning and sterilization of components, parts and equipment Maintaining equipment, area and cleaning logbooks Cleaning sanitizing production rooms and equipment, Stocking production and cleaning supplies Author/ review/improve SOP s, batch records, protocols and technical reports Actively participates in training activities, managing their individual training plan. Utilizes Manufacturing knowledge to train others, improve process operations and affect positive change and demonstrates ability to troubleshoot basic mechanical operations. Knowledge, Competencies And Skills EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS: Advanced knowledge of current Good Manufacturing Practices (cGMP s). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups. Experience with cGMP Biotech or Pharmaceutical operations cGMP: Understands cGMP requirements and follows those requirements, including requirements for good documentation practices. Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups). Possess excellent written and oral communication skills. Possesses advanced knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management. Possesses advanced understanding of the scientific theory of biologics manufacturing: understands biotechnology processing - purpose of major unit operations and microbial control concepts Actively pursues learning of required skills, new skills, and new equipment Must have the ability to work either Day or Night shift. Physical Demands Is required to stand, operate manufacturing equipment, computer equipment; and is required to wear personal protective equipment (PPE) such as safety shoes, safety glasses and/or hearing protection. May be required occasionally to lift, push, or pull up to 50 pounds during handling of production equipment and/or materials. May be required to climb occasionally (use of stepladders/stairs in production areas, or stairwells in work campus). May be required to bend, kneel, or crawl rarely when troubleshooting production equipment. May be required to stand and walk frequently and/or for extended periods while overseeing production activities. May be required to drive rarely to attend offsite meetings and/or training.

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