Senior Technician (Process), Operations

MSD • Wilson, NC

3d • $63,800 - $100,400

About The Position

The Senior Technician (Process), Operations role provides front-line process leadership, tactical direction, and subject-matter expertise for packaging operations. The position assists Operations Managers with 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 complying with cGMP and site procedures.

The Senior Technician executes operations activities on assigned lines, including operating and setting up equipment, executing 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, including in-process challenges and controls, TOCS, repackaging, and batch notes/MES exception creation. It is the 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 position 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. It supports safe and compliant manufacturing and packaging, accurate documentation and batch release, team development, cross-functional collaboration, and continuous improvement.

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 Operations Technician (Process) experience 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.
• Experience executing and reviewing batch records and following 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.
• Willingness and ability 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.
• SME 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 motivation to work autonomously, organize priorities, and work with other team members.
• Strong communication 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, including TOCS, 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-related issues to Maintenance and Engineering, and provide 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, liaise across shifts and functions, ensure batch information flows, and follow up on actionable items.
• 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 efforts 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 personal conduct and attendance policies.
• Perform and train staff in line-clearance and contamination-prevention procedures.
• Promote 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 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.
• Collaborate on the development, review, and updating of 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 compliance with 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 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.
• Use interpersonal skills, leadership, and conflict resolution to support team 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 in a timely manner.

Benefits

• Annual bonus and long-term incentive, if applicable.
• Medical, dental, vision, healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED