Specialist, Engineering

Merck & Co.•Wilson, NC

5d•Hybrid

About The Position

Our engineers and scientists support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our technical personnel have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. Summary, Focus and Purpose 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 & commercial readiness of the vaccine manufacturing facility as well as providing future routine operational support. For their area of assignment, the selected candidate will be the technical subject matter expert for all aspects of tech transfer, validation, licensure, start up, and ongoing technical support. 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, troubleshooting 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 process 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 Education Bachelor's degree or higher in Science or Engineering field (Engineering preferred)

Requirements

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 to support multi-shift operation on an extended or as needed basis
Adaptability
Adaptability
Analytical Instrumentation
Automation Systems
Bioprocessing
Capital Projects
cGMP Compliance
Change Control Processes
Change Request Management
Computerized Maintenance Management Systems (CMMS)
Continuous Process Improvement
Data Analysis
Detail-Oriented
Electrical Systems
Global Manufacturing
Lean Manufacturing
Lean Product Development
Maintenance Supervision
Mechanical Systems
Organizational Change Management
Pharmaceutical Packaging
Process Control
Regulatory Compliance
Regulatory Inspections
SAP Manufacturing Execution (SAP ME)

Nice To Haves

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

Responsibilities

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, troubleshooting and validation activities
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
Ensure that Technical related activities for area of assignment are managed such that process deliverables and timelines are well defined in advance and met
Recommend continuous improvement, productivity, and capital projects for the IPT
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