**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, Blow-Fill-Sealing (BFS), Inspection, Packaging, etc.) located in aseptic and clean room environments 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. **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 team-based Employee Involvement culture, focusing on continuous improvement of Wilson Operations + Operate and assist in trouble-shooting 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 blow-fill-seal, single use mixer, high-voltage 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, 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 + 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 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 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 DEP’s (Documentation Errors - Production), 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 (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 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 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 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. Competencies | Leadership Behaviors | Skills Empowering leadership; Flexibility; Motivation; Functional Excellence; Teamwork/Collaboration; Results-Oriented; Professional Maturity; Problem-Solving; 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 PAS-X/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 \#MSJR Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/) **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** No Travel Required **Flexible Work Arrangements:** Not Applicable **Shift:** 1st - Day, Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 05/23/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R348678