• Facility start-up will include design, commissioning, equipment qualification and vaccine drug product process demonstration in support of facility licensure
• 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
• 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
• 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

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• 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

$117,000.00 - $184,200.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits