Sr. Specialist, Engineering

MSD•Wilson, NC

6d•Hybrid

About The Position

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, Validation and Process Improvement. The Senior Specialist, Vaccines Technology position is responsible for providing technical support to primary filling, inspection, and/or packaging operations within the RotaTeq® Pod vaccine manufacturing facility at the Wilson, NC Site. This position is for an individual contributor and member of the Technical Team within the RotaTeq® POD Integrated Process Team (IPT). This is an engineering role focused on the start-up and commercialization 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 tech transfer, start up, validation, licensure, and ongoing technical production 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. Lead troubleshooting and optimization activities within the RotaTeq® POD facility Lead or support ongoing initial qualification, validation or re-qualification activities Resolve and escalate technical issues impacting supply within the daily, weekly, and monthly IPT management processes. Provide ownership for Manufacturing Execution System (MES) batch record creation or updates, and facilitate changes as needed to support business needs. 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 Technical subject matter expert during regulatory inspections for area of assignment. Ensure that process development and validation data is generated and documented in a manner that supports successful licensure and positive interactions with regulatory agencies. Execute change management for the RotaTeq® POD IPT and provide scientific/technical justification for proposed changes to support business needs. Investigate via the Deviation Management process, determine root cause, and implement robust Corrective Action and Preventive Actions for any process related compliance discrepancies noted during day to day activities and/or audits. Escalate as per IPT management processes. Cost Ensure that technical startup activities for area of assignment are managed such that project deliverables and timelines are well defined in advance and management-approved timelines are met. Recommend continuous improvement, productivity, and capital projects for the IPT. Continuous Improvement Execute projects that support the strategic goals of the IPT. Maintain a culture of continuous improvement focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving.

Requirements

Minimum 5 years of relevant industry work experience, with minimum 3 years' experience providing technical / development support to pharmaceutical unit operations
Demonstrated ability to work independently as team member
Demonstrated strong interpersonal skills with ability to influence, collaborate, 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
Willing to work irregular hours to support multi-shift operation on an as needed or extended basis
Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols, etc.
Applied Engineering
Applied Engineering
Business Management Tools
Contractor Oversight
Corrective Action Management
Customer Service
Detail-Oriented
Driving Continuous Improvement
Engineering Design
Engineering Standards
Facility Management
Lean Manufacturing
Lean Product Development
Mechatronics
OSHA Regulations
Pharmaceutical Packaging
Process Engineering
Regulatory Inspections
Regulatory Requirements
SAP Manufacturing Execution (SAP ME)
Standard Operating Procedure (SOP) Writing
Technical Problem-Solving
Technology Startups
Utilities Management
Vendor Management

Nice To Haves

Experience with aseptic filling, qualified inspection processes, or pharmaceutical packaging and serialization/aggregation.
Experience leading aseptic manufacturing or packaging projects and investigations
Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies
Familiarity with Change Execution Management tools
Working knowledge of Systems Applications and Products (SAP) and 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 (advanced Excel, statistical software packages (Minitab), etc.)
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.
Lead troubleshooting and optimization activities within the RotaTeq® POD facility
Lead or support ongoing initial qualification, validation or re-qualification activities
Resolve and escalate technical issues impacting supply within the daily, weekly, and monthly IPT management processes.
Provide ownership for Manufacturing Execution System (MES) batch record creation or updates, and facilitate changes as needed to support business needs.
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 Technical subject matter expert during regulatory inspections for area of assignment.
Ensure that process development and validation data is generated and documented in a manner that supports successful licensure and positive interactions with regulatory agencies.
Execute change management for the RotaTeq® POD IPT and provide scientific/technical justification for proposed changes to support business needs.
Investigate via the Deviation Management process, determine root cause, and implement robust Corrective Action and Preventive Actions for any process related compliance discrepancies noted during day to day activities and/or audits.
Escalate as per IPT management processes.
Ensure that technical startup activities for area of assignment are managed such that project deliverables and timelines are well defined in advance and management-approved timelines are met.
Recommend continuous improvement, productivity, and capital projects for the IPT.
Execute projects that support the strategic goals of the IPT.
Maintain a culture of continuous improvement focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving.