Senior Technician, Operations (2nd Shift)
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Under the direction of the Operational Coach, operates automatic packaging equipment as part of an empowered work team. Routinely performs line-specific duties including line check-in, in-process quality monitoring, equipment operation, work center cleaning and change-over and material movement with a high degree of accuracy and efficiency in accordance with established procedures.
Primary Activities include, but are not limited to:
- Carry out our mission by assuring finished goods and services are of the highest quality, optimal cost, and delivered on schedule.
- Function as a role model in our team-based Employee Involvement culture, focusing on continuous improvement of Wilson Operations.
- Operate and assist in trouble-shooting and problem resolution for processes and packaging equipment.
- Assist coaches and operators with operational, mechanical and technical activities that supports our production standards while following GMPs and SOPs.
- Perform and train others in the cleaning and inspection of equipment between production batches.
- A team leader and trainer in the set up and adjust of production equipment, including tablet fillers, thermoformers, cappers, labelers, checkweighers, cartoners, casep, and palletizers, and other assemblies as appropriate, as needed for optimal performance within qualified parameters.
- Examine products to detect defects, product damage, or other visual quality problems.
- Assist coaches with managing the accuracy of critical information, and ensure the completion of required documentation for production processes are in order for optimal line performance.
- Identify, trouble-shoot, and offer resolution for equipment malfunctions and repair needs; communicate and manage appropriately with coach for timely resolution. Accurately manages areas to ensure the maintenance of detailed records as it relates to equipment cleaning, set-up, and challenge documentation.
- Assists coaches to ensure operational concerns are visible and solutions and/or continuous improvement actions are taken with an appropriate sense of urgency for appropriate resolution.
- Leads and contributes to the effectiveness of operations and implementation of viable continuous improvement initiatives.
- Leads the charge to ensure standard work areas are in a constant state of compliance with respect to proper housekeeping, material segregation, and personal gowning including required protective equipment.
- Demonstrates a strong mechanical aptitude and ability to troubleshoot and effectively communicate within noted time constraints.
- Supports off-shifts and weekend work as required for this position.
- Interacts with other departments – MMS and Quality to ensure all packaging operations are performed in accordance with current Good Manufacturing Practices (cGMP), site Standard Operating Procedures (SOPs) and Divisional policies and guidelines.
- Identifies, raises, and assist with the management of quality issues.
- Troubleshoot and offer resolution and recommendation to coaches; appropriately gather and provide information for corrective actions.
- Works with coaches, Quality, Maintenance, and Planing to appropriately inform all parties of quality deviations; supports all investigations and corrective actions. Performs and train others on line clearance activities thoroughly to prevent cross-contamination of products.
- Conforms to established safety procedures in accordance with OSHA and other regulatory agencies.
- Recognizes, utilize, and encourage others to use safety equipment when/as needed.
- Champion for and actively takes accountability for personal safety as well as the safety of others.
- Identifies, reports, and documents unsafe conditions, participates in the investigation of accidents/injuries and corrective measures.
- Operates and train others to use packaging equipment within qualified parameters; performs and documents equipment challenges per current procedures. Demonstrates mechanical abilility to troubleshoot, problem solve, and train others to recognize and solve equipment concerns as it relates to product jams and component problems.
- Identifies and communicate effectively, equipment problems to assist the mechanics with corrective repairs.
- Understands and communicates requirments for achieving packaging Profit Plan standards; assist coaches in communication of the production schedule to complete monthly orders.
- Contribute to achieving all departmental financial goals by understanding, communicating, and controlling labor tracking, component usage and material waste.
- Team/Individual Performance
- Actively assist coaches in leading a team-based culture through participation in team meetings and continuous improvement activities.
- Demonstrates a high degree of maturity, leadership, and personal integrity.
- Strictly adheres to all site policies on personal conduct and attendance.
- Collaborates and communications with peers and other employees at various levels throughout the organization; demonstrates leadership and conflict-resolution ability.
- Demonstrates a willingness to provide and receive constructive feedback in 360 performance review.
- Assists the coach with coordination of daily work schedules and effectively communicate daily customer service and performance targets.
- Works with Quality, Maintenance, and Planning to resolve quality issues on the line.
- Works with Packaging coaches to gather information needed for quality and safety investigations and robust CAPA’s.
- Provides training to others, develops training documents and procedures to facilitate effective processes for new operators.
- Resolves and reports issues with product accountability and SAP system problems.
- Assists with troubleshooting equipment and process related occurrences across all of the packaging lines.
- Provides guidance to others with documentation actions in the SAP PI sheets and paper records.
- Interacts with MMS personnel to resolve component issues, including incoming quality concerns.
- Responsible for problem solving and process improvement initiatives.
- Assists with management and actions that come out of the Tier 1 meetings and escalate issues to the Tier 2 process.
- Works with the coach to determine root cause for line downtime that causes misses for SA and delivery.
- Reviews Parsec data, resolve DEP’s, and make SOP changes as appropriate.
- Demonstrates a strong mechanical aptitude with the ability to trouble-shoot and communicate appropriately and effectively.
- Reviews completed process orders to ensure there are no DEQ’s.
Education Minimum Requirement:
- High School Diploma or advanced degree
- Minimum of three (3) years of experience in a FDA regulated industry
- Must have excellent verbal and written communication skills
- Must possess the ability to work with others effectively, displaying strong interpersonal and organizational skills
- Experience in peer training activities is required
- Associates Degree or higher in Business, Science, or Technology
- Yellow Belt certified or Kata training
- Strong computer skills with experience using SAP
- Understanding of Lean principles and Continuous Improvement acumen
- Strong mechanical and technical skills
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Job: Production / Operator
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck