Under the direction of the Operational Coach (Manager), this senior position operates and assists coaches with managing automatic solid-dose packaging equipment as part of an empowered work team. Routinely performs and lead 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
Senior Operator Responsibilities:
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 support 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, case packers, 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
Quality: 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 Planning 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.
Safety: 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.
Equipment: Operates and train others to use packaging equipment within qualified parameters; performs and documents equipment challenges per current procedures. Demonstrates mechanical ability 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.
Financial: Understands and communicates requirements 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.
Additionally, the Senior Operator will:
1. Assists the coach with coordination of daily work schedules and effectively communicate daily customer service and performance targets.
2. Works with Quality, Maintenance, and Planning to resolve quality issues on the line.
3. Works with Packaging coaches to gather information needed for quality and safety investigations and robust CAPA's.
4. Provides training to others, develops training documents and procedures to facilitate effective processes for new operators.
5. Resolves and reports issues with product accountability and SAP system problems.
6. Assists with troubleshooting equipment and process related occurrences across all of the packaging lines.
7. Provides guidance to others with documentation actions in the SAP PI sheets and paper records.
8. Interacts with MMS (Materials Management Specialists) personnel to resolve component issues, including incoming quality concerns.
9. Responsible for problem solving and process improvement initiatives.
10. Assists with management and actions that come out of the Tier I meetings and escalate issues to t.l1e Tier 2 process.
11. Works with the coach to determine root cause for line downtime that causes misses for SA (Schedule Adherence) and delivery.
12. Review Parsec data, resolve DEP's (Documentation Errors - Production), and make SOP changes as appropriate.
13. Demonstrates a strong mechanical aptitude with the ability to trouble-shoot and communicate appropriately and effectively
14.Reviews completed process orders to ensure there are no DEQ's (Documentation Errors - Quality).
High School Diploma or equivalent
Competencies/Leadership Behaviors/Skills: All positions require proficiency in the following competencies: Empowering leadership; Flexibility; Motivation; Functional Excellence; Teamwork/Collaboration; Results-Oriented; Problem-Solving; Communication.
Other Requirements: (Knowledge; education/degree in what preferred field; min. years of experience in what work area; certification or license requirement, etc.)
Required Experience: Minimum of three (3) years' experience in an 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.
Desirable: AAS 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.
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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Travel Requirements:No Travel Required
Flexible Work Arrangements:Not Specified
Shift:3rd - Night
Valid Driving License:No
Number of Openings:1