Senior Technician (Process), Operations

MSD•Wilson, NC

2d•$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 cGMP and site-procedure compliance. The technician executes operations on assigned lines, including operating and setting up equipment, conducting equipment challenges, monitoring equipment performance 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 SME for assigned operations, such as in-process challenges and controls, Time Out of Controlled Storage (TOCS), re-packaging, and Batch Notes/MES exception creation. It is a day-to-day escalation point for process and quality questions and partners with other areas 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 drive sound decisions and corrective actions under time-sensitive conditions. The position is a regular, third-shift night role. The posting lists an annual salary range of $63,800–$100,400 and eligibility 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 as an Operations Technician (Process) 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 or MES.
Demonstrated leadership ability, including peer training and coaching and developing others.
Experience executing and reviewing batch records and adhering to Good Documentation Practices.
Experience with formal problem-solving techniques and hands-on 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.
Must pass a vision exam and be free of color blindness.
Correctable close-vision acuity equivalent to 20/20.
Must be medically cleared and physically capable of passing annual occupational health evaluations for respirator use, including a PAPR.

Nice To Haves

SME-level experience with SAP, MES, PasEx, Tracksys, electronic logbooks, or other production execution systems.
SME-level knowledge of operations processes such as TOCS, re-packaging, and Batch Note creation.
Formal Lean/continuous-improvement training and hands-on experience implementing CI projects.
Ability to support technical writing of documents such as SOPs.
Ability and drive to work autonomously, organize priorities, and work with team members.
Outstanding communication within the direct team and across multiple shifts.
Competencies in 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.
Act as the process subject-matter expert for assigned operations, including TOCS, re-packaging, and Batch Notes creation.
Manage the accuracy and flow of critical production information.
Conduct 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 resolve component issues and incoming quality concerns.
Help determine 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 actionable items are addressed.
Support actions from Tier 1 meetings and escalate items to Tier 2 as needed.
Help control labor, component usage, and material waste in support of departmental financial goals.
Review line performance data and system trends, identify issues, and recommend actions.
Participate in qualification, validation, and technical documentation activities as required.
Maintain work areas in top condition for safe and efficient operations.
Conduct manufacturing and packaging operations in accordance with cGMP, site SOPs, and divisional policies.
Adhere to site policies on personal conduct and attendance.
Perform and train staff in online 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 CAPA implementation, and initiate incidents in CLUE or participate in quality investigations.
Participate in audits and inspections and ensure local readiness and compliance.
Collaborate on developing, reviewing, and updating SOPs, work instructions, forms, and other batch-related documents.
Coach team members on Good Documentation Practices, data integrity, correct procedural execution, and adherence.
Ensure personal and team adherence to health and safety policies, gowning, PPE, and housekeeping standards.
Lead or contribute to continuous-improvement initiatives, including 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.
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.
Demonstrate interpersonal skills, empowering leadership, 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.
Help assure finished goods and services meet quality, cost, and delivery expectations.