Specialist, Engineering -1

Job Overview At the Durham Vaccine Facility in Durham, North Carolina, the Global Vaccine Technology & Engineering (GVTE) Team is seeking an IPT Engineering professional to partner with Manufacturing Operations, Quality Operations, and Process Automation. The role supports a sterile fill‑finish, lyophilization vaccine manufacturing facility that produces live virus vaccines. Responsibilities Author and execute validation protocols. Draft and manage Quality Notifications (QNs). Provide technical support to manufacturing shop floor for in‑process analytics, controls, and troubleshooting. Analyze complex processing problems using critical analytical thinking and on‑floor troubleshooting. Develop scientific justification for planned material and process/equipment changes. Coordinate with Operations, Automation, and Quality to scope investigations, determine root causes, implement corrective actions, and complete trending analysis. Prepare and review regulatory filings, process descriptions, investigations, and change requests. Participate in domestic and international regulatory agency inspections. Support quality and safety initiatives. Communicate progress of projects to supervisor and recommend improvements to production procedures. Provide on‑shift support during critical manufacturing runs such as aseptic process simulation, protocol execution, and developmental runs. Generate process change controls and implement changes for drug product equipment/process. Qualifications Education Bachelor of Science in Chemical Engineering, Biochemical Engineering, Bioengineering, or a related life science field with at least two (2) years of relevant experience. Master of Science degree is also acceptable. Required Experience and Skills Experience in vaccine or biologics manufacturing within a cGMP environment. Experience authoring technical documentation (investigations, protocols, reports, or change controls) in a cGMP context. Demonstrated systematic problem‑solving skills. Leadership with influence and outstanding written and presentation skills. Ability to foster a collaborative work environment. Preferred Experience and Skills On‑floor cGMP manufacturing support, providing immediate responses to deviations and supply chain interruptions. Authored process change controls and deviation investigations. Validation documentation and execution experience. Experience with SAP, MES, and DeltaV. Reading Piping and Instrumentation Diagrams. Lean Six Sigma belt certification. Process risk assessment tools. Experience handling regulatory questions with agencies such as FDA and EMA. Face‑to‑face presentation of technically complex subjects to regulatory inspectors. Technology transfer methodologies for introduction/launch of a cGMP product. Required Skills Adaptability and initiative. Biodesign, biological engineering, and life science knowledge. Change control and corrective action management. Data analysis, equipment troubleshooting, and Good Manufacturing Practices (GMP). Lean manufacturing, process optimization, and process simulation. Professional integrity, project management, and risk assessment. Additional Information Salary range: $87,300.00 – $137,400.00, based on education, qualifications, certifications, experience, and location. Eligible for annual bonus and long‑term incentive if applicable. 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. Shift: 1st day. Work arrangement: Hybrid. Travel: 10% required. Equal Employment Opportunity Statement 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 embrace diversity and encourage a collaborative environment that respects different perspectives and ideas. #J-18808-Ljbffr MSD Malaysia