Job Summary: 

Responsible for performing assembly, packaging, and labeling of medical products with a higher level of proficiency, in compliance with GMP requirements, BD procedures, and quality standards. This role operates manufacturing equipment across multiple processes, ensures product quality, and supports manufacturing operations by troubleshooting issues, assisting in process execution, and promoting adherence to safety and operational standards. Additionally, this position provides support to other areas and helps reinforce process awareness among associates. 

Demonstrates initiative, willingness, and a positive attitude to continuously develop skills and knowledge within certified operations. Promotes process awareness among associates and contributes to personal and team development through daily performance. 

Job Responsibilities: 

• Perform assembly, packaging, and labeling of medical devices and pharmaceutical products in compliance with GMP, SOPs, and quality standards. 

• Operate and be certified in multiple manufacturing processes or groups of operations across different areas. 

• Execute production activities using batch records, job aids, SOPs, and product specifications. 

• Interpret manufacturing documentation to ensure accurate and efficient process execution. 

• Perform in-process and final visual inspections to ensure product and packaging meet quality requirements. 

• Accurately complete and review batch records, production logs, and documentation in compliance with GMP, GDP, FDA, and ISO standards. 

• Meet daily production targets in alignment with the established day-by-hour production plan. 

• Monitor, capture, and report downtime, scrap, and production performance metrics. 

• Coordinate execution of manufacturing schedules for assigned batches or operations. 

• Ensure availability of required materials before initiating operations. 

• Handle, segregate, and dispose of non-conforming materials in accordance with established procedures. 

• Maintain cleanliness and organization of work areas, equipment, and operations in alignment with 5S and cleanroom standards. 

• Support manufacturing-related activities including calibration, work orders, and validation processes as required. 

• Identify, troubleshoot, and communicate production issues, risks, or deviations to the supervisor or designee in a timely manner. 

• Support and maintain a safe work environment, including participation in safety programs such as Employee Safety Observations (ESO). 

• Follow all safety requirements and properly use personal protective equipment (PPE), including but not limited to lab coats, gloves, hair/beard covers, shoe covers, hearing protection, eye protection, and specialized cleanroom garments as required. 

• Maintain regular attendance and punctuality in accordance with company policies. 

• Maintain positive working relationships with peers and supervisors. 

• Maintain open communication to ensure operational issues and changes are communicated and resolved in a timely manner. 

• Provide guidance, training, and knowledge sharing to other associates as needed. 

• Teach and explain operational processes to other associates as required to support effective process execution and knowledge transfer. 

• Support continuous improvement initiatives, including 5S, standardization, and process simplification. 

• Participate in Kaizen events and Level 1 Shift Kickoff Meetings as required. 

• Suggest improvement opportunities related to equipment, processes, quality, or workplace organization. 

• Provide backup support across multiple equipment, operations, or areas as required. 

• Support production continuity by covering operational activities and assisting in other areas when business needs require it. 

• Communicate issues, concerns, and potential risks that may impact product quality or manufacturing processes. 

• Comply with all company policies and regulatory requirements. 

• Perform other duties as assigned. 

Education and Experience: 

Education:  

• Completed High School or equivalent preferred. 

Experience:  

• 1 to 3 years of experience in a high paced medical manufacturing environment.  

Knowledge and Skills: 

Professional Skills 

• Knowledge of EH&S standards and safety procedures (required). 

• Strong understanding of manufacturing processes and production flow (required). 

• Knowledge of GMP and Quality Systems; familiarity with GDP is required. 

• Ability to interpret and apply manufacturing documentation (e.g., SOPs, batch records, specifications). 

• Ability to perform inspections and testing activities (visual, in-process, and final product verification). 

• Intermediate troubleshooting and problem-solving skills related to equipment, processes, and set-up conditions. 

• Basic understanding of equipment maintenance principles. 

• Awareness of escalation processes for quality, safety, or production issues. 

• Basic mathematical skills (addition, subtraction, multiplication, division, fractions, decimals, and percentages). 

• Basic computer skills, including proficiency in a Windows environment and Microsoft Office (Outlook, Word, Excel). 

• Effective oral and written communication skills; bilingual Spanish/English preferred. 

• Ability to work independently and within cross-functional teams. 

• Familiarity with product attributes, manufacturing components, and material identification. 

• Root cause analysis and problem-solving methodology. 

• Understanding of occupational health requirements and safe work practices. 

Technical & Operational Skills 

• Ability to operate multiple manufacturing processes across different areas based on certification level. 

• Demonstrates technical knowledge as a subject matter resource within assigned operations. 

• Ability to ensure material readiness and proper flow within assigned processes. 

• Understanding of non-conforming material handling and disposition processes. 

• Ability to support and guide other associates in process execution as needed (operations trainer support). 

Leadership & BD Excellence 

• Demonstrates teamwork and leadership awareness aligned with The BD Way. 

• Ability to train, guide, and support other associates in daily operations. 

• Knowledge of Lean principles and 5S; ability to apply them in the workplace. 

• Basic understanding of continuous improvement concepts. 

• Demonstrates initiative, adaptability, and willingness to support changing business needs. 

• Actively participates in continuous improvement and team-based problem-solving activities. 

Physical Demands: (if applicable) 

• Cleanroom or controlled manufacturing setting required protective gear. 

Work Environment: (if applicable) 

• Manufacturing.