Description:
Manufacturing Equipment Operator I Shift: 1st shift Schedule: Days - TBD, 6:00 AM to 2:30 PM JOB INFORMATION Job Description Name: Manufacturing Equipment Operator I - RTD JOB SUMMARY Contributes to business safety, quality, and delivery. Works with team to operate and use automated and semi-automated equipment and systems to perform basic tasks related to fill manufacturing operations under moderate to close supervision. Recognizes and elevates equipment, safety, and product problems, contributing to the achievement of production goals. Utilizes validated software systems (SAP, ETQ, Agile/MyPLM) to maintain process, batch records, ensure compliance to Quality, and maintain inventory control. Maintains all production related documentation in compliance with Quality System Regulations. Specific assembly job function may change based on functional team assignment. Responsibilities • Participates in the operation of filling, labeling & packaging equipment of varying complexity and in accordance with Production Manufacturing Records, applicable SOPs, and ISO and cGMPs requirements to produce finished intermediates and final kits while meeting quality and production targets. • Learns and operates automated systems/equipment, and sequences of operation, including: Equipment setup, operation, and cleaning; Monitoring and troubleshooting equipment. Adheres to manufacturing schedule in order to meet deadlines while sustaining quality, cost, delivery, and safety metrics. • Utilizes validated production systems as part of Manufacturing documentation and Inventory management. • Inspects and conducts “In-Process” testing of finished product for quality compliance. • Recognizes, communicates, and escalates equipment and safety related issues beyond basic faults. • Maintains and improves 6S in the work area and cleans & decontaminates work surfaces in accordance with defined procedures. Performs duties in accordance with SOPs, QSRs, and all safety regulatory requirements. • Utilizes validated production systems (SAP, ETQ, Agile/MyPLM) as part of Manufacturing documentation and Inventory management. • Performs warehousing activities according to defined procedures, which may include picking, issuing, returns, internal distribution of goods, receiving, shipping, etc., as required. • Operates in a LEAN Manufacturing Environment and participates in process improvements. Demonstrates a Continuous Improvement mindset. • Speaks Up and challenges the status quo, helping provide and support improvements. • Stays up to date on internal training requirements. • Performs other duties as required or assigned. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities. Formal Training/Education Education Level Education Details: H.S. Diploma or GED - REQUIRED Experience Years of Experience: 1 year Experience working with automated Manufacturing Equipment or computer systems in a Quality controlled environment; will accept no experience with Associates degree in a related field - REQUIRED Knowledge, Skills and Abilities • Ability to complete applicable On-The-Job (OJT) training within 60 days of start date. - REQUIRED • Basic knowledge of automated systems and equipment. - REQUIRED • Ability to work within a team environment in a culture of accountability and professionalism. - REQUIRED • Ability to complete routine tasks. - REQUIRED • Written and verbal comprehension of the English language. - REQUIRED • Ability to interpret and understand production documents and drawings to complete tasks. - REQUIRED • Must have a working knowledge of standard computer programs. - REQUIRED • Basic mathematical comprehension (addition, subtraction, multiplication, division, percentages). - REQUIRED • Ability to work with cross functional teams. - REQUIRED • Ability to adhere to Lean, 6S, and safety policies and procedures - REQUIRED Travel Requirements: As needed, Based on business needs