Senior Specialist, Vaccines Technology

MSD•Wilson, NC

1d•$117,000 - $184,200•Onsite

About The Position

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.

Requirements

Bachelor’s degree or higher in Science or Engineering field (Engineering preferred)
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.
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

Nice To Haves

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

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.
Provide content ownership for Manufacturing Execution System batch record and facilitate changes as needed to support business needs.
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.
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.
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.