Merck · 1 week ago
Senior Specialist, Engineering
Lansdale, PA
Full-time
Onsite
Mid, Senior Level
$117K/yr - $184K/yr
4+ years expMerck is a leading company in the vaccine manufacturing industry, and they are seeking a Senior Specialist in Engineering to support the start-up of a new live virus vaccine filling and lyophilization facility. The role involves leading technical initiatives, partnering with cross-functional teams, and providing technical expertise to ensure successful facility and process licensure.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
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
Qualification
Required
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
Preferred
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
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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