Specialist Engineering - Incoming Materials

Job description

Job Description Our company aspires to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and use the power of leading-edge science to save and improve lives around the world. West Point, PA Technical Operations for the Incoming Materials (IM) team is seeking a highly motivated individual for a Specialist, Engineering position. The successful candidate will partner with Suppliers, IM Quality, Planning, Procurement, Validation, Warehouse, Supplies Inspection, Global IM Tech Ops, Supplier Development & Performance Development, and Supplier Quality Management to ensure that the incoming materials used across the West Point site support the manufacture of the highest quality vaccines. Responsibilities Execute change management for supplier-initiated changes and site-initiated incoming material projects. Author and update GMP technical documents and SOPs to support incoming material qualification and change control. Design and conduct experimental protocols to support incoming material qualification, testing, and improvement projects. Provide technical support for Warehouse, Supplies Inspection, and incoming materials used in manufacturing areas across the West Point site. Lead or support execution of Quality Risk Assessments. Support regulatory inspection activities for the facility. Support IM Deviation Management team investigations and Corrective/Preventative Actions (CAPAs) if necessary. Improve Right-First-Time performance and prevent/reduce deviations. Support and/or execute continuous improvement projects to increase compliance, simplify/standardize processes, resolve release issues, and gain efficiencies. Manage project timelines to ensure key compliance and customer due dates are met; escalate potential delays, and develop remediation plans when possible. Support team safety, environmental, and compliance objectives. Qualifications Required Bachelor’s Degree or higher (Engineering or Sciences, preferred) Minimum two (2) years post-bachelor’s degree experience in GMP manufacturing/laboratories and/or technical support of GMP manufacturing operations/laboratories. Experience in change control and/or project support role. Highly developed communication, leadership, and teamwork skills. Ability to manage projects/work to schedule/deadlines. Preferred Experience in biologics, vaccine, or bulk sterile manufacturing facilities. Change Control author Supplier Change Notification experience Project Management Technical Writing Required Skills: Adaptability, Biopharmaceutical Industry, Biopharmaceutical Operations, Biopharmaceutics, Change Controls, Change Management, Continuous Improvement Projects, Data Analysis, Engineering Principle, Engineering Standards, Estimation and Planning, Experimentation, GMP Compliance, Improvement Projects, Process Optimization, Professional Engineering, Project Management, Quality Risk Assessment, Software Proficiency, Supplier Quality Management, Teamwork, Technical Communication, Technical Problem-Solving Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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 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 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 The salary range for this role is $87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. 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: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 08/1/2026*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.