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Incumbent will be trained in the set-up, operations, and troubleshooting of the equipment in the production areas. Additional duties will include documentation of work and specific computer functions. Must integrate company initiatives such as LEAN into work practices. Responsible for safely producing vaccines which meet all product specifications in accordance with current Good Manufacturing Practice standards.
Accountabilities: 1-A).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. 1-I). Outcome of review of compliance records and audits, as well as Deviation rate and Management assessment.2-A). Understands, performs and teaches others basic 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.2-I) Overall equipment effectiveness, Deviation rate, and Management assessment. 3-A). To oversee 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. 3-I). Overall process effectiveness, Deviation rate and Accident Rate and Management assessment.4-A). Basic 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 and other as needed. 4-I). Workflow initiation and approval process to ensure all information is present and accurate, as well as Management assessment. 5-A). To generate or collect new ideas about workplace and processes. 5-I). Management assessment
- Bachelor’s Degree in Microbiology or other related field and/or Associate’s Degree plus 2 years’ experience and/or High School diploma plus 4 years’ experience.
- Basic computer skills with Word, Excel and Electronic Management Systems,
- Basic 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.
- Ability to operate applicable ERP system.
- Requires basic knowledge of manufacturing function, acquaintance with and general understanding of aspects of the production process and ability to apply this knowledge to situations ordinarily encountered.
- Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Management & Economic Magnitude: This position oversees the production floor processes and personnel, however, is not responsible for management of personnel, discipline or performance management.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status