Senior Technician (Process), Operations

MSD•Wilson, NC

20h

About The Position

The Senior Technician (Process), Operations provides front-line process leadership, tactical direction, and subject-matter expertise for packaging operations. The role supports Operations Managers in coordinating line activities, resolving process and product quality issues, maintaining accurate production documentation, and driving continuous improvement to maximize line performance, product quality, and on-time delivery while meeting cGMP and site requirements. The Senior Technician performs operations on assigned lines, including operating and setting up equipment, executing equipment challenges, monitoring equipment and product quality, cleaning work areas, moving materials, troubleshooting routine equipment and process issues, training, and resolving issues. The position serves as the primary process subject-matter expert for assigned operations, such as in-process challenges and controls, Time Out of Controlled Storage (TOCS), repackaging, and Batch Notes/MES exceptions. It is also the day-to-day escalation point for process and quality questions and works with other teams to minimize downtime, reduce errors, and improve first-time quality. The role requires leadership, communication, process knowledge, problem-solving, attention to detail, and the ability to make sound decisions and drive corrective actions under time-sensitive conditions. The position works in a GMP manufacturing and packaging setting and supports multi-shift operations.

Requirements

High school diploma or equivalent.
At least 4 years of experience in a GMP manufacturing facility.
At least 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 such as 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 application, including root cause analysis and Lean Six Sigma tools.
Strong verbal and written communication skills and ability to influence and collaborate across shifts and functions.
Ability to lift up to 50 lbs.
Willingness to work irregular hours to support multi-shift operations and/or weekends as needed.
Must pass a vision exam and be free of color blindness.
Must have vision correctable to 20/20 for close work.
Must be medically cleared and physically capable of passing annual occupational health evaluations for respirator use, including a PAPR.

Nice To Haves

Subject-matter-expert-level experience in SAP, MES, PasEx, Tracksys, electronic logbooks, or other production execution systems.
Subject-matter-expert knowledge of operations processes such as TOCS, repackaging, and Batch Note creation.
Formal Lean/continuous improvement training and hands-on experience implementing continuous improvement projects.
Ability to support technical writing of documents such as SOPs.
Demonstrated ability and drive to work autonomously, organize priorities, and work with other team members.
Outstanding communication within the direct team and across multiple shifts.
Competencies include empowering leadership, flexibility, motivation, teamwork and collaboration, results orientation, problem-solving, and communication.

Responsibilities

Assist Operations Managers with coordinating daily production activities to meet schedule adherence and customer requirements.
Serve as the process subject-matter expert for assigned operations, including TOCS, repackaging, and Batch Notes creation.
Manage the accuracy and flow of critical production information.
Perform visual inspections of products, packaging, and production areas during line clearance, in-process checks, repackaging, and material reintroduction.
Identify potential production issues, take action to prevent them, and communicate equipment-related issues to Maintenance and Engineering with accurate troubleshooting information.
Use root cause analysis tools to identify causes of quality and safety events and support corrective and preventive actions.
Provide SAP/MES operational support, resolve non-routine system issues, and assist others.
Work with Materials Management to resolve component issues and incoming quality concerns.
Help determine root causes of line downtime affecting schedule adherence and delivery, and support corrective actions.
Participate in or lead Tier meetings as needed, act as a liaison across shifts and functions, and ensure batch information and action items are communicated and addressed.
Support management actions from Tier 1 meetings and escalate items to Tier 2 as required.
Help control labor, component usage, and material waste in support of departmental financial goals.
Review line performance data and system trends to identify issues and recommend actions.
Participate in qualification, validation, and technical documentation activities as required.
Maintain work areas in condition to support safe and efficient operations.
Conduct manufacturing and packaging operations in accordance with cGMP, site SOPs, and divisional policies.
Follow site policies on personal conduct and attendance.
Perform and train staff in line clearance and contamination prevention procedures.
Take accountability for personal and team safety by reporting and resolving unsafe conditions.
Review electronic and paper production batch documentation for completeness, accuracy, and availability.
Expedite batch record issue resolution with Quality and Operations Managers to support on-time batch release.
Identify and raise quality issues, support investigations, and assist with CAPA implementation with Quality, Maintenance, and Planning.
Initiate incidents in CLUE and/or participate in quality investigations.
Participate in internal and external audits and inspections and maintain local readiness and compliance.
Help develop, review, and update SOPs, work instructions, forms, and other batch-related documents.
Coach team members in Good Documentation Practices, data integrity, procedural execution, and adherence.
Ensure team adherence to health and safety policies, gowning, PPE, and housekeeping standards.
Lead or contribute to continuous improvement activities such as 5S, GEMBA, and root cause analysis to reduce deviations, errors, variability, and downtime and improve throughput and first-time quality.
Participate in safety, quality, and production improvement activities and identify and execute improvement actions.
Promote safety good catches and Safe by Choice behaviors and drive actions to mitigate identified risks.
Train, coach, and mentor operators; assess training needs; develop training materials and procedures; and serve as primary train-the-trainer for key processes.
Demonstrate empowering leadership, interpersonal skills, conflict resolution, and the ability to lead team-based culture and performance improvement.
Communicate across shifts and functions and present technical findings, improvement proposals, and investigation outcomes clearly.
Collaborate with cross-functional teams to prioritize repairs and improvements and communicate issues promptly.