Senior Specialist, Engineering

MSD

1d•Hybrid

About The Position

Our Engineers support internal and external manufacturing operations, ensuring they 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. Summary, Focus and Purpose The West Point, PA campus is our Company’s largest vaccine manufacturing facility with more than 2000 employees. This facility manufactures bulk and/or final dosage forms for all company vaccine products and is growing to meet the vaccine demands of the future. The GSEC Builders team is seeking a highly motivated individual to fill an open position to support the start-up of a new live virus vaccine filling and lyophilization facility. Facility start-up will include design, commissioning, equipment qualification and vaccine drug product process demonstration in support of facility licensure. The Building 50 Live Virus Vaccine Drug Product Manufacturing team is seeking a highly motivated individual to fill an open position to support the start-up of a new vaccine filling & lyophilization facility at the West Point site. Facility start-up will include design, commissioning, equipment qualification and live virus vaccine drug product process demonstration in support of facility licensure. The Senior Specialist, Technical Operations will be responsible for equipment and facility delivery as well as other process licensure activities in support of technical transfer of vaccine products to the new facility. This role will actively support, participate in, and embrace an empowered team culture. In this role, the Sr. Specialist will work as an individual contributor as well as a leader within a cross-functional group that includes Global Engineering Services, Technical Operations, West Point Operations, Quality, Automation, and others.

Requirements

Bachelor’s degree in an Engineering or Science Related field with five years in GMP manufacturing and/or technical support of GMP manufacturing operations or Master’s degree in an Engineering or Science Related field with four years in GMP manufacturing and/or technical support of GMP manufacturing operations
Demonstrated strong performance record and excellent project management skills.
Principled verbal and written communications.
Experience in biologics, vaccine or sterile manufacturing facilities.
Highly developed communication, leadership and teamwork skills.
Adaptability
Change Control Processes
Customer-Oriented
Engineering Processes
Global Manufacturing
GMP Compliance
Good Manufacturing Practices (GMP)
Manufacturing Process Validation
Oral Communications
Process Documentation
Process Optimization
Production Process Development
Project Management
Regulatory Compliance
Regulatory Submissions
Risk Control Assessment
Root Cause Analysis (RCA)
Strategic Thinking
Teamwork
Technical Transfer
Written Communication

Nice To Haves

Experience leading cross-functional project teams.
Regulatory inspection presentation experience with external regulatory authority representatives.
Technology transfer or facility start-up experience.
Strong understanding of process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies.

Responsibilities

Lead technical initiatives associated with new facility startup and qualification in support of both product transfer(s) and commercial production of lyophilized LVV products.
Partner with a cross functional team to develop processes/procedures and complete successful qualification of equipment/process.
Provide technical expertise for unit operation for process hazard assessments, quality risk assessments, and qualification.
Support execution of the technical transfer strategy of a live virus vaccine product to a new manufacturing facility.
Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.
Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
Support process improvement projects and complex manufacturing investigations.
Support digital and data integrity initiatives for the project.
Provide technical support to manufacturing for complex problems and issues.
Develop and assure consistent application of standardized work, engineering, and process tools.
Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
Support regulatory submission preparation and inspections for the facility.