Senior Specialist, Operations

Job Description As part of our company's Vaccine Manufacturing Organization, the Durham team is seeking a highly motivated individual to serve as a Senior Operations Specialist within the Operations Manufacturing Support team. In this role, you must be able to work efficiently in a fast-paced environment and be hands‑on when called for by the situation. This role requires the ability to distill large quantities of complex data into simplified reporting and actionable measures, strong problem-solving skills, rapid disciplined decisions and prioritization of work. The position must also demonstrate strong collaboration and communication skills to enable interfacing with both internal contacts (site level) and external contacts (external customers, sister sites, vendors) to support these initiatives. The position requires strong leadership, technical writing, and problem-solving skills. You will lead and/or support critical project initiatives at the site, support the ongoing sterility assurance program, and be involved in developing and implementing corrective actions.Enthusiasm for continuously learning is a requirement. Responsibilities Supports the end‑to‑end product Value Stream Map driving production improvements, inventory management, cost reductions, and standard work at the shop floor level. Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes remediation projects, as required. Assists shift managers in providing leadership to the production floor. Capable of providing primary leadership to team during extended periods of manager absence such as vacations. Serves as liaison between the team and support groups in resolving day to day issues and in support of various projects and initiatives including the tech transfer of new products. Author and own execution of Operations protocols. Develop and own Operations corrective actions. Author and revise Standard Operating Procedures. Support of internal and external regulatory inspections, presenting on topics as needed. Executes and manages Operations batch record review within established timelines for release and effectively liaisons with Quality to resolve comments in a timely manner. Day shift Operations representative for various site needs (Quality Assessments, Process Simulation support, etc.). Leads/Supports production and quality projects and process system improvements. Lead problem‑solving of real‑time shop floor issues. Support investigations of process deviation events. Provide expertise to the production floor, understanding the full process requirements (safety, compliance, equipment, regulatory) in order to best understand and resolve production issues. Works independently and is capable of balancing shifting priorities without introducing disruption to the organization. Capable of working through uncertainty with minimal levels of manager direction. Potential to work on shift directly with an Operations team as needed for shop floor support. Education Minimum Requirement Bachelor Degree (science/chemical, mechanical, or electrical engineering preferred) Bachelor of Science (B.S.) degree in Engineering (such as Chemical, Mechanical, Bio-Engineering, Bio-Medical Engineering, Industrial Engineering, etc.) or Science Fields (such as Chemistry, Biology, Microbiology, etc.) strongly preferred. Required Experience and Skills Minimum five (5) years of relevant experience in a manufacturing, technical, or mechanical support role in a high‑volume lean operation. Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols. Must be able to work both independently and within multi‑functional teams in a fast‑paced environment. Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry. Experience with formal problem‑solving techniques and a hands‑on approach to problem‑solving, such as root cause analysis and/or Lean Six Sigma tools. Experience using inventory management and maintenance planning software (MRP/ERP) such as SAP, automated control systems and electronic batch record systems. Experience managing against metrics and scorecards in a business environment. Experience with presenting to an internal / regulatory auditor. Advanced knowledge of Excel, Minitab, JMP, and/or Statistical analysis. Six Sigma certification. Preferred Experience and Skills Sterile manufacturing shop floor experience highly preferred. Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry. Experience with formal problem‑solving techniques and a hands‑on approach to problem‑solving, such as root cause analysis and/or Lean Six Sigma tools. Experience using inventory management and maintenance planning software (MRP/ERP) such as SAP, automated control systems and electronic batch record systems. Experience managing against metrics and scorecards in a business environment. Experience with presenting to an internal / regulatory auditor. Advanced knowledge of Excel, Minitab, JMP, and/or Statistical analysis. Six Sigma certification. Required Skills Analytical Problem Solving cGMP Compliance Collaboration Competency Management Corrective Action Management Data Analysis Decision Making Manufacturing Processes Operations Support Process Improvements Production Scheduling Regulatory Management Root Cause Identification Site Operations Standard Operating Procedure (SOP) Technical Writing Training and Development Vaccine Manufacturing Working Independently We offer a comprehensive package of benefits. Benefits medical, dental, vision healthcare and other insurance benefits (for employee and family) retirement benefits, including 401(k) paid holidays vacation compassionate and sick days More information about benefits is available at The salary range for this role is $96,200.00 - $151,400.00. 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. 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. 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. 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. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 08/27/2026 The application deadline for this position is stated on this posting. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. #J-18808-Ljbffr MSD Malaysia