Senior Technician, Operations

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First Quality Always mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials intermediates and finished products.

Under the direction of the Operational Coach (Manager) this senior position operates and assists coaches with managing vaccine Operations areas (Single Use Mixing BlowFillSealing (BFS) Inspection Packaging etc.) located in aseptic and clean room environments as part of an empowered work team. Routinely performs and lead linespecific duties including line checkin inprocess quality monitoring equipment operation work center cleaning and changeover and material movement with a high degree of accuracy and efficiency in accordance with established procedures.

Primary 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 teambased Employee Involvement culture focusing on continuous improvement of Wilson Operations

• Operate and assist in troubleshooting and problem resolution for filling packaging & inspection 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 lead trainer in the set up and adjust of production equipment including blowfillseal single use mixer highvoltage leak detector labelers cartoners printers 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 troubleshoot 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 setup 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 offshifts and weekend work as required for this position

• 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 coaches to gather information needed for quality and safety investigations and robust CAPAs

• 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 the filling packaging lines

• Provides guidance to others with documentation actions in the SAP PI sheets and paper records. Interacts with MMS (Materials Management Specialists) 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 (Schedule Adherence) and delivery

• Reviews Parsec data resolve DEPs (Documentation Errors Production) and make SOP changes as appropriate

• Demonstrates a strong mechanical aptitude with the ability to troubleshoot and communicate appropriately and effectively

• Reviews completed process orders to ensure there are no DEQs (Documentation Errors Quality)

• Perform other duties as requested by the Operations coach.

Quality

Interacts with other departments MMS and Quality to ensure all filling/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 crosscontamination 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 filling packaging & inspection 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 operating unit 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 teambased 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 conflictresolution ability. Demonstrates a willingness to provide and receive constructive feedback in 360 performance review.

Competencies Leadership Behaviors Skills

Empowering leadership; Flexibility; Motivation; Functional Excellence; Teamwork/Collaboration; ResultsOriented; Professional Maturity; ProblemSolving; Communication.

Education Minimum Requirement

• High School Diploma or equivalent

Required Experience and Skills

• Minimum of three (3) years 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

• Peer training activities

• Effective and efficient computer skills with experience using SAP and PASX/MES

Preferred Experience and Skills

• Associate of Applied Science (AAS) degree or higher in Business Science or Technology; Yellow Belt certified or Kata training

• Understanding of Lean principles and Continuous Improvement acumen

• Effective mechanical and technical skills

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