Senior Specialist, Vaccines Technology

Job Description At our company, our Engineers support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. The Senior Specialist, Vaccines Technology Operations position is responsible for providing technical leadership or support to the primary filling, inspection, and/or packaging operations within the vaccine manufacturing facility at the Wilson, NC Site. This position will be an individual contributor (with potential to have people management responsibilities), and member of the Technical Operations team within our product POD Integrated Process Team (IPT). This is an engineering role focused on commercial ramp up of the vaccine manufacturing facility as well as providing future routine operational support. This role will act as the technical subject matter expert for all aspects of validation and ongoing technical support for their area of assignment. Primary activities for this position will include, but not be limited to: Delivery Utilize technical expertise, experience, independent judgment, and decision-making to build robust processes that support consistent and reliable supply. Resolve and escalate technical issues impacting supply within the daily, weekly, and monthly IPT management processes. Provide content ownership for Manufacturing Execution System batch record and facilitate changes as needed to support business needs. Compliance Ensure that assigned processes are developed or maintained in a robust manner and defined such that vaccines filled at the Wilson site consistently meet critical quality attributes. Act as Technical subject matter expert during regulatory and internal inspections for area(s) of assignment and interact with inspection officials during audits Ensure that process development, validation/qualification or re-qualification data is generated and documented in a manner that supports positive interactions with internal inspections and regulatory agencies. Execute change management for our product POD IPT (with Veeva Vault) and provide scientific/technical justification for proposed changes to support business needs. Author quality deviation reports through: investigating, determining root cause, and implementing robust Corrective Action and Preventive Actions for any process related compliance discrepancies noted during day-to-day activities and/or audits. Escalate these events as per IPT management processes. Cost Ensure that technical validation activities for area of assignment are managed such that validation or other technical related deliverables and timelines are well defined in advance and met. Recommend continuous improvement, productivity, and capital projects for the IPT. Team Partner with Operations, Quality, Automation, Plant Engineering and other groups to execute projects that support the strategic goals of our product POD IPT. Maintain a culture of continuous improvement focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving. Actively participate on cross-functional teams in an inclusive manner to advance projects goals and achieve deliverables. Education Minimum Requirement: Bachelor’s degree or higher in Science or Engineering field (Engineering preferred) Required Experience and Skills: Minimum 5 years of relevant industry work experience, with minimum 2 years of experience providing validation and/or technical process support to pharmaceutical unit operations Demonstrated ability to work independently and as a team member Demonstrated strong interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry Ability to work onsite at least 5 days per week Ability to work irregular hours to support multi-shift operation on an as needed basis Ability to work from ladders or work platforms Experience supporting regulatory inspections including FDA Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols, technical summaries etc. Preferred Experience and Skills: Experience with aseptic filling, aseptic process simulations, CIP/SIP systems, single-use components Experience leading vaccine manufacturing projects, investigations, risk assessments Experience with Change Execution Management tools SAP / MES working knowledge Experience working in a CBER regulated environment Demonstrated data analysis skills and experience analyzing process control limits (advanced Excel, statistical software packages (Minitab, JMP), etc.) Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, Right First-Time methodologies Required Skills: Adaptability, Capital Project Management, Change Management, Data Analysis, Deviation Management, Equipment Qualification, Facility Management, Good Manufacturing Practices (GMP), Maintenance Supervision, Occupational Safety and Health, Regulatory Audits, Sterile Manufacturing, Team Leadership, Troubleshooting, Vaccine Manufacturing 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​ </p