Senior Technician (Process), Operations

Job description

Job Description POSITION OVERVIEW – Basic Functions & Responsibility     Essential functions include, but are not limited to: The Senior Technician (Process), Operations role provides front-line process leadership, tactical direction, and subject-matter expertise for packaging operations. This role assists Operations Managers in coordinating line activities, resolving process and product quality issues, ensuring accurate production documentation, and driving continuous improvement to maximize line performance, product quality, and on-time delivery while ensuring compliance with cGMP and site procedures. The Senior Technician (Process) will execute operations activities, including operate equipment, perform equipment setup, execute equipment challenges, monitor equipment performance and product quality during production, clean work areas, move materials accurately and efficiently, perform routine equipment/process troubleshooting, training, and issue resolution, on the assigned line(s). This role serves as the primary process SME for assigned operations (e.g., In-process challenges and controls, Time Out of Controlled Storage (TOCS), Re-packaging, Batch Notes/MES Exception creation, among others), acts as the day-to-day escalation for process and quality questions, and partners with other areas to minimize downtime, reduce errors, and improve first-time quality. This position requires strong leadership and communication skills, strong process knowledge and problem-solving skills, exceptional attention to detail, and the ability to drive correct decisions and corrective actions under time-sensitive conditions. PRIMARY ACTIVITIES Primary activities include, but are not limited to: • Operations o Assist Operations Managers with coordination of daily production activities to meet schedule adherence and customer requirements. o Act as the process subject-matter expert (SME) for assigned operations (e.g., TOCS, Re-packaging, Batch Notes creation, etc.). o Manage the accuracy and flow of critical production information. o Perform visual inspections of products, packaging, and production areas during line clearance, in-process checks, repackaging, and material reintroduction. These tasks require distinguishing fine visual details, printed information, and product or component colors. o Apply process knowledge to proactively identify potential production issues, takes action to prevent occurrence and/or communicate equipment-related issues to Maintenance and Engineering; provide accurate information to support troubleshooting. o Use root cause analysis tools to identify true root causes for quality and safety events and support implementation of corrective and preventive actions. o Provide SAP/MES operational support; resolve non-routine system issues and assist others. o Work with MMS/Materials Management to resolve component issues and incoming quality concerns. o Assist Operations Managers in determining root cause for line downtime impacting Schedule Adherence (SA) and delivery and support corrective actions. Participate and/or lead (when needed) Tier meetings, act as liaison between shifts, teams, IPTs, and other areas to facilitate batch information flow and ensure actionable items are addressed. o Support management actions coming out of Tier 1 meetings and escalating items to Tier 2 as required. o Contribute to departmental financial goals by monitoring and helping control labor, component usage and material waste. o Review line performance data and other system trends to identify issues and recommend actions to address, as appropriate. o Participate in qualification, validation and technical documentation efforts as required. o Ensure areas are maintained in top condition to support safe and efficient operations. o Carry out Our Company's site mission by assuring finished goods and services are of the highest quality, optimal cost, and delivered on schedule. • Compliance o Conduct all manufacturing and packaging operations in accordance with current Good Manufacturing Practices (cGMP), site SOPs and divisional policies. o Strictly adheres to all site policies on personal conduct and attendance. o Perform and train staff online clearance and contamination prevention procedures to reduce risk of mix-ups or cross contamination. o Take accountability for personal and others' safety by reporting and resolving unsafe conditions. o Responsible for reviewing production batch documentation (electronic and paper) to ensure it is complete, accurate, and available. o Responsible for expediting batch record issue resolution in collaboration with Quality and Operations Managers to ensure on-time batch release. o Identify, raise, and assist with management of quality issues; support investigations and CAPA implementation with Quality, Maintenance and Planning. o Initiate incidents in CLUE and/or participate in quality investigations. o Participate in internal and external audits and inspections and ensure local readiness and compliance. o Collaborate to develop, review and update SOPs, work instructions, forms and other batch-related documents as required. o Coach team members in Good Documentation Practices/data integrity in all production records and on correct procedural execution and monitor adherence. o Ensure personal and team adherence to health and safety policies, proper gowning, PPE and housekeeping standards. • Collaboration and Teamwork o Lead and/or contribute to continuous improvement initiatives (5S, GEMBA, root cause analysis) to reduce deviations, human errors, variability and downtime while improving throughput and first-time quality. o Attend and actively participate in safety, quality and production-related improvement activities and proactively identify and execute improvement actions. o Champion safety good catches and exemplify Safe by Choice behaviors, driving implementation of actions to mitigate identified risks. o Train, coach and mentor operators: assess training needs, develop training materials and procedures, and act as primary train-the-trainer for key process activities. o Demonstrate strong interpersonal skills, empowering leadership, conflict resolution, and the ability to lead team-based culture and performance improvement. o Communicate effectively across shifts and functions; prepare and present technical findings, improvement proposals and investigation outcomes in a clear and concise manner. o Collaborate with cross-functional teams to prioritize repairs and improvements and ensure timely communication of issues. SKILLS (include specific skill levels to apply Our Company's Leadership Principles): a) Education Requirements • High School Diploma or equivalent b) Requirements • 4 plus years of experience in a GMP manufacturing facility. • Minimum 3 years of leadership experience in a direct GMP manufacturing or packaging setting and/or prior experience in an Operations Technician (Process) role with demonstrated leadership skills. • Robust understanding of cGMP requirements related to manufacturing and packaging execution. • Demonstrated ability to work with computerized and automated systems (SAP, MES, or equivalent). • Demonstrated leadership ability including peer training experience and the ability to coach and develop others. • Demonstrated experience in batch record execution and review and adherence to good documentation practices. • Demonstrated experience with formal problem-solving techniques and hands-on approach (root cause analysis, Lean Six Sigma tools). • Strong verbal and written communication skills; ability to influence and collaborate across shifts and functions. • Must be able to lift up to 50 lbs. • Must be willing to work irregular hours to support multi-shift operation and/or weekends as needed. • Must pass a vision exam and be free of color blindness. • Must be equivalent to 20/20 correctable close vision acuity. • Must be medically cleared and physically capable of