Technician III, Bio / Pharma Production M-F 7:30am-4pm, APU2, Building P

Description

Duties & Responsibilities

• Perform duties associated with aseptic processes, weighing, measuring, counting, calculations, sampling, and verifications required for biological production processes in accordance with batch production records (BPR) and in compliance with current good manufacturing practice (cGMP) standards, all current safety standards and site procedures.
• Complete understanding and can perform advanced operation of production equipment and ensures all equipment, instruments and production materials are released and available for use. Look up and perform transactions within the electronic inventory management system.
• Perform advanced equipment and process troubleshooting
• Leads production processes, cleaning, environmental monitoring and personnel and perform in-process batch quality checks per the written procedures. Knows and follows safety rules, wears appropriate safety equipment and maintains proper safety practices at all times. BL-3 technicians are required to participate in the BIAH Encephalomyelitis Program without health restrictions.
• Advanced computer skills to create and update standard operating procedures and write deviation reports, and to complete all training as assigned to include general company procedures, area procedures, equipment operation, computer operation, safety, GMP, BPE, and other as needed.
• To generate or collect new ideas about workplace and processes.
• Performs all Company business in accordance with all regulations (e.g., USDA, OSHA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business
• contacts in order to maintain BIAH´s excellent reputation in the community.

Requirements

• Bachelors degree from an accredited institution in Microbiology or other related Science, plus one (1) year of relevant experience; Or an Associates degree from an accredited institution in Microbiology or other related Science, plus three (3) years of relevant experience; Or a High School Diploma, plus five (5) years of relevant experience.
• Advanced computer skills with Word, Excel and Electronic Management Systems, advanced biological equipment knowledge and/or experience (i.e. fermentation, centrifuge, concentration units), basic understanding of biological organisms.
• Ability to read, interpret and conform to batch records, Quality and Safety requirements.
• Advanced with FDA, USDA, EU, and EPA regulations.
• Demonstrated ability to assist maintenance and process engineering in troubleshooting.
• Complies with all the business compliance requirements of current Good Manufacturing Practices (cGMP), Housekeeping, Environmental, Safety, and Security.
• Ability to operate applicable ERP system.
• Requires advanced knowledge of manufacturing function, acquaintance with and general understanding of detailed aspects of the production process and ability to apply this knowledge to problems and situations ordinarily encountered.
• Required to apply knowledge in the training of others.