**Job Description** Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Senior Specialist, Incoming Material PPC Subject Matter Expert, will be responsible for providing technical support for the Core Site Service’s Incoming Materials team supporting all the manufacturing operations at the West Point site to remain operational, continuously improve, and innovate. The incumbent will work primarily as an individual contributor but will also have leadership responsibility for complex projects pertaining to new Primary Packaging Component incoming materials and Supply Inspection process which have the potential for sitewide impact to the sterile drug substance and drug product areas. Senior Specialists are expected to fully manage all aspects of assigned projects, including but not limited to stakeholder management, issues identification and resolution, quality collaboration, and drive all aspects of project in alignment with established timelines. Also, additional support will be required for run the business work such as change control, process improvements, direct shop floor support of Supplies Inspection and warehouse, deviation management support, and assessment of supplier driven initiatives. The Senior Specialist will be accountable for delivery of work required to meet business objectives and ensure uninterrupted supply of primary packaging components to downstream customers. In this role, the technical expert will be responsible for training junior engineers and supporting an empowered team culture with a focus on knowledge sharing, teamwork, open communications, and collaboration. **Activities for this position include:** + Support the IM technical portfolio of work to maintain compliant supply and meet business objectives, including communication of status to leadership and various stakeholders. + Operate with a high degree of independence, assuring alignment with appropriate functional leaders and stakeholders while advancing the team’s assigned portfolio of initiatives. The incumbent will collaborate and engage with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Planning, Procurement, Finance, Above Site Technology, Regulatory, among others. + Help manage team resources and prioritizes as aligned with business needs to include process/project support, and continuous improvement activities – e.g., improve safety/compliance, help reduce cost, and increase consistency and efficiency. Support recruitment and hiring of team members as necessary. + Provide technical guidance to team members or customers as well as anticipate and interpret the customer needs to identify solutions. Includes authoring and review of technical documentation including protocols, deviation management, qualification, change control, validation etc. as required. Assists in presenting technical discussions to regulatory agencies during inspections. **Importantly, the individual must:** + Provide strong technical knowledge and demonstrate collaboration acumen. + Demonstrate skill in process/project management. + Proven record in change execution management, and strong analytical, communication and interpersonal skills. + Collaborate with internal stakeholders and external partners (Suppliers) as needed to achieve business goals. **Minimum Education Requirement and Experience:** + Bachelors of Science (B.S) Degree in Chemical Engineering, Biological Engineering, Mechanical Engineering, Chemistry, or related technical field with five (5) years of manufacturing or development experience in the areas of biologics, vaccine, or bulk sterile manufacturing facilities; **OR** + Masters of Science (M.S.) Degree in Chemical Engineering, Biological Engineering, Mechanical Engineering, Chemistry, or related technical field with three (3) years of manufacturing or development experience in the areas of biologics, vaccine, or bulk sterile manufacturing facilities; **OR** + Ph.D. in Chemical Engineering, Biological Engineering, Mechanical Engineering, Chemistry, or related technical field with one (1) year of manufacturing or development experience in the areas of biologics, vaccine, or bulk sterile manufacturing facilities **Required Experience and Skills:** + Minimum of two (2) years’ experience in performing Change Controls (Authoring or Quality Approval) + Technical expertise in the development or support of bulk biologics or vaccine processes Including but not limited to: Primary Packaging Components and Supply Inspection areas. + Proven track record in collaborating with cross-functional teams for delivery of complex projects + Ability to manage multiple projects/tasks simultaneously. + Demonstrated skill in portfolio management + Highly developed communication, leadership and teamwork skills Demonstrated technical writing and problem solving skills. + Ability to maintain strong working relationships with technical, quality and operations peers in the internal and external network. **Preferred Experience and Skills:** + Regulatory inspection presentation experience with external regulatory authority representatives. + Demonstrated technical capabilities in operational excellence and six sigma methods with the ability to drive innovation and productivity using digital technology and data to analyze and simplify work. + Supplier change management and/or supply chain management experience including but not limited; Incoming Material, Supplies Inspection, Deviation Management and Primary Packaging Components, Warehouse, and Quality. 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. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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​ Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 02/25/2025 ***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:** R334335