Senior Technician (Process), Operations

Merck•Wilson, NC

3d•$63,800 - $100,400

About The Position

The Senior Technician (Process), Operations provides front-line process leadership, tactical direction, and subject-matter expertise for packaging operations. The 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 maintaining compliance with cGMP and site procedures. The Senior Technician executes operations activities on assigned lines, including operating and setting up equipment, performing equipment challenges, monitoring equipment performance and product quality, cleaning work areas, moving materials, troubleshooting routine equipment and process issues, training, and resolving issues. The role serves as the primary process SME for assigned operations and as the day-to-day escalation point for process and quality questions, partnering with other functions to minimize downtime, reduce errors, and improve first-time quality. This position requires strong leadership, communication, process knowledge, and problem-solving skills; exceptional attention to detail; and the ability to make sound decisions and drive corrective actions under time-sensitive conditions. The position is a regular, third-shift (night) role. The salary range is $63,800–$100,400, and the successful candidate may be eligible for an annual bonus and long-term incentive, if applicable.

Requirements

High school diploma or equivalent.
More than 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 executing and reviewing batch records and adhering to Good Documentation Practices.
Demonstrated experience with formal problem-solving techniques and hands-on use of root cause analysis or Lean Six Sigma tools.
Strong verbal and written communication skills and the ability to influence and collaborate across shifts and functions.
Ability to lift up to 50 pounds.
Willingness to work irregular hours to support multi-shift operations and/or weekends as needed.
Ability and willingness to wear a respirator for short periods as required and comply with respiratory protection program requirements.

Nice To Haves

SME-level experience with SAP, MES, PasEx, Tracksys, electronic logbooks, or other production execution systems.
Subject-matter expertise in operations processes such as Time Out of Controlled Storage, 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 standard operating procedures.
Demonstrated ability and drive to work autonomously, organize priorities, and work with other team members.
Outstanding communication skills within the direct team and across multiple shifts.
Competencies and leadership behaviors: empowering leadership, flexibility, motivation, teamwork/collaboration, results orientation, problem-solving, and communication.

Responsibilities

Assist Operations Managers in coordinating daily production activities to meet schedule adherence and customer requirements.
Serve as the process subject-matter expert for assigned operations, such as Time Out of Controlled Storage, repackaging, and batch note 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 preventive action, communicate equipment issues to Maintenance and Engineering, and provide information to support troubleshooting.
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 address 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, serve as a liaison across shifts, teams, IPTs, and other areas, 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 needed.
Monitor and 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 good 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.
Promote personal and team safety by reporting and resolving unsafe conditions; ensure adherence to safety policies, gowning, PPE, and housekeeping standards.
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 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 support 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, and correct procedural execution, and monitor adherence.
Lead or contribute to continuous improvement initiatives, including 5S, GEMBA, and root cause analysis, to reduce deviations, human 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.
Champion 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 process activities.
Promote teamwork and performance improvement through interpersonal skills, empowering leadership, and conflict resolution.
Communicate across shifts and functions; prepare and present technical findings, improvement proposals, and investigation outcomes clearly and concisely.
Collaborate with cross-functional teams to prioritize repairs and improvements and communicate issues promptly.
Support the site mission by helping ensure finished goods and services meet quality, cost, and delivery objectives.