Specialist, Engineering -1

Job Description At the Durham Vaccine Facility in Durham, North Carolina, the Global Vaccine Technology & Engineering (GVTE) Team is seeking candidates to fill IPT Engineering positions to partner with Manufacturing Operations, Quality Operations and Process Automation. GVTE provides technical engineering and manufacturing support for the production of our Company's live virus vaccines at Durham. Position Description We currently have an exciting opportunity for an Engineer to join our vaccine manufacturing Technical Operations department within our Company's Manufacturing Division, supporting a sterile fill, finish, lyophilization vaccine manufacturing facility in Durham, NC. This state‑of‑the‑art facility, started in 2004, is manufacturing our Company's lifesaving vaccines. The IPT (Integrated Process Team) Support Specialist will be part of a cross‑functional team charged with the technical support of the manufacturing shop floor in a fill‑finish vaccine facility, specifically supporting the Inspection part of the process. This role requires the ability to execute multiple projects and activities across the IPT. Strategic and effective communication and collaboration skills are essential. The successful candidate will also have robust problem‑solving skills and a hands‑on approach to equipment validation and problem solving, with a bias toward going to see problems for oneself in the field as they arise. Enthusiasm for continuously learning is a requirement. Responsibilities include but are not limited to: Authoring and executing validation protocols Authoring Quality Notifications (QNs) Providing technical support to manufacturing shop floor for in‑process analytics, controls, and troubleshooting Analyzing complex processing problems through critical analytical thinking and on the floor troubleshooting Development of sound scientific justification for planned material and process/equipment changes Working with the Operations, Automation, and Quality functions to determine the breadth and scope of investigations to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition Preparing and/or providing guidance and review for regulatory filings, process descriptions, investigations, and change requests. Acts as a participant in domestic and international regulatory agency inspections Supporting all quality and safety initiatives Keeping the supervisor current on the progress of projects, and making improvement recommendations on production procedures Supporting on shift support during critical manufacturing runs such as aseptic process simulation, protocol execution, and developmental runs Responsible for authoring process change controls and completing tasks to implement drug product equipment/process changes Position Qualifications Education Minimum Requirement: Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of two (2) years of relevant experience or a Master of Science Degree Required Experience and Skills: Experience in vaccine or biologics manufacturing within a cGMP environment Experience authoring technical documentation (technical investigations, protocols, reports, or change controls) within a cGMP context Demonstrated systematic problem‑solving skills Proven leader with influence and outstanding communication (written & presentation) skills Ability to foster a collaborative work environment Preferred Experience and Skills: Experience with on‑the‑floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions Authored process change control Authored deviation investigations Experience with validation documentation and execution Experience with SAP Experience with Manufacturing Execution Systems (MES) Experience with Delta V Ability to read Piping and Instrumentation Diagrams is desired Lean Six Sigma belt certification Experience with process risk assessment tools Experience with responding to regulatory questions with multiple agencies (e.g. FDA, EMA) Experience with face‑to‑face presentation of technically complex subjects to regulatory inspectors Experience with technology transfer methodologies for introduction/launch of a cGMP product Required Skills Adaptability, Biodesign, Biological Engineering, Biological Sciences, Change Control Management, Chemical Engineering, Corrective Action Management, Data Analysis, Equipment Troubleshooting, Good Manufacturing Practices (GMP), Lean Manufacturing, Life Science, Manufacturing, Personal Initiative, Process Optimization, Process Simulation, Professional Integrity, Project Management, Risk Assessments, Risk Control Assessment, Root Cause Analysis (RCA), SAP Manufacturing Execution (SAP ME), SAP PP (Production Planning), Technical Writing Preferred Skills Current Employees apply HERE; Current Contingent Workers apply HERE 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 and EEOC GINA Supplement. Compensation and Benefits The salary range for this role is $87,300.00 - $137,400.00. The salary will be based on relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and organizational needs. Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, health care 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 Application Process You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. Legal and Regulatory Information 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. Job Details 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): NA Job Posting End Date: 07/21/2026 #J-18808-Ljbffr EyeBio