Merck
Vaccines Technology Specialist
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 diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. The Vaccines Technology Specialist position is responsible for providing technical support to primary filling, inspection, and/or packaging operations within the vaccine manufacturing facility at the Wilson, NC Site. This position will be an individual contributor and member of the Technical Operations Team within the Rota-POD Integrated Process Team. This is an engineering role focused on the technical readiness of the vaccine manufacturing facility as well as providing future routine operational support. The selected candidate will be the technical subject matter expert for all aspects of tech transfer, validation, licensure, start up, and ongoing technical support for their area of assignment. Key Functions: 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 Lead or support equipment process development and validation activities Compliance: Ensure that assigned processes are developed in a robust manner and defined such that vaccines filled at the Wilson site consistently meet critical quality attributes Act as or support technical subject matter expert(s) during regulatory inspections for area of assignment Ensure that process development and validation data is generated, documented and presented in a manner that supports successful licensure and positive interactions with regulatory agencies Lead or support change management for the Rota-POD IPT and provide scientific/technical justification for proposed changes to support business needs Investigate, determine root cause, and implement robust Corrective Action and Preventive Actions and author quality investigations for any applicable process related compliance discrepancies noted during day-to-day activities and/or audits, and escalate these issues per IPT management processes Cost: Ensure that Technical related activities for area of assignment are managed such that project deliverables and timelines are well defined in advance and met Recommend continuous improvement, productivity, and capital projects for the IPT Continuous Improvement: Execute projects that support the strategic goals of the Rota-POD IPT Maintain a culture of continuous improvement focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving Required Education: Bachelor's degree or higher in Science or Engineering field (Engineering preferred) Required Experience | Knowledge | Skills: Two years of relevant industry work experience, with one year experience providing technical/development support to pharmaceutical unit operations Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols, etc. Demonstrated ability to work independently as team member Demonstrated strong interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment Willing to work irregular hours (as needed) to support a multi-shift operation's shop-floor activities Preferred Experience | Knowledge | Skills: Experience with aseptic filling, qualified inspection processes, pharmaceutical packaging and/or serialization/aggregation Experience in production ramp up of capital projects Experience in authoring quality deviations Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies Familiarity with Change Execution Management tools Working knowledge with Systems Applications and Products (SAP) / Manufacturing Execution System (MES) Experience working in a Center for Biologics Evaluation and Research (CBER) regulated environment Demonstrated data analysis skills and experience setting up process control limits using advanced Excel and/or statistical software packages (Minitab or JMP) Experience supporting regulatory inspections including FDA
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 diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. The Vaccines Technology Specialist position is responsible for providing technical support to primary filling, inspection, and/or packaging operations within the vaccine manufacturing facility at the Wilson, NC Site. This position will be an individual contributor and member of the Technical Operations Team within the Rota-POD Integrated Process Team. This is an engineering role focused on the technical readiness of the vaccine manufacturing facility as well as providing future routine operational support. The selected candidate will be the technical subject matter expert for all aspects of tech transfer, validation, licensure, start up, and ongoing technical support for their area of assignment. Key Functions: 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 Lead or support equipment process development and validation activities Compliance: Ensure that assigned processes are developed in a robust manner and defined such that vaccines filled at the Wilson site consistently meet critical quality attributes Act as or support technical subject matter expert(s) during regulatory inspections for area of assignment Ensure that process development and validation data is generated, documented and presented in a manner that supports successful licensure and positive interactions with regulatory agencies Lead or support change management for the Rota-POD IPT and provide scientific/technical justification for proposed changes to support business needs Investigate, determine root cause, and implement robust Corrective Action and Preventive Actions and author quality investigations for any applicable process related compliance discrepancies noted during day-to-day activities and/or audits, and escalate these issues per IPT management processes Cost: Ensure that Technical related activities for area of assignment are managed such that project deliverables and timelines are well defined in advance and met Recommend continuous improvement, productivity, and capital projects for the IPT Continuous Improvement: Execute projects that support the strategic goals of the Rota-POD IPT Maintain a culture of continuous improvement focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving Required Education: Bachelor's degree or higher in Science or Engineering field (Engineering preferred) Required Experience | Knowledge | Skills: Two years of relevant industry work experience, with one year experience providing technical/development support to pharmaceutical unit operations Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols, etc. Demonstrated ability to work independently as team member Demonstrated strong interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment Willing to work irregular hours (as needed) to support a multi-shift operation's shop-floor activities Preferred Experience | Knowledge | Skills: Experience with aseptic filling, qualified inspection processes, pharmaceutical packaging and/or serialization/aggregation Experience in production ramp up of capital projects Experience in authoring quality deviations Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies Familiarity with Change Execution Management tools Working knowledge with Systems Applications and Products (SAP) / Manufacturing Execution System (MES) Experience working in a Center for Biologics Evaluation and Research (CBER) regulated environment Demonstrated data analysis skills and experience setting up process control limits using advanced Excel and/or statistical software packages (Minitab or JMP) Experience supporting regulatory inspections including FDA