Specialist, Engineering -1

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. We currently have an exciting opportunity for an Engineer to join our vaccine manufacturing Technical Operations department within out 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 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 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 {+ 2 more} Equity and Inclusion 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. Requirements: 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. Compensation & Benefits 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 #J-18808-Ljbffr Merck