Senior Specialist, Engineering- Technical Lead for Live Virus Vaccine (LVV)
Senior Specialist, Engineering- Technical Lead for Live Virus Vaccine (LVV)
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Job Description
Job Description
Vaccines tech product leadership (V-TPL) within large molecule science and technology (LMS&T) is seeking a highly motivated individual for the role of Sr. Specialist Engineering. This role will provide end-to-end support of manufacturing science and technology for commercial vaccine products including Drug Substance Drug Product and Analytics.
We are seeking a Sr. Specialist to join our Live Virus Vaccine (LVV) team. The successful candidate will provide technical support for LVV franchises with potential to support ERVEBO and/or Rotateq collaborating with manufacturing sites in West Point PA; Wilson NC; and Burgwedel Germany. The successful candidate will partner with the team Technical Product Leader as well as site Technical Operations and other key members of the Technical Product Council to implement the prioritized portfolio of projects in support of the franchise strategic goals. This will include implementation of innovative technical solutions and operational improvements to achieve targets for safety compliance supply and productivity for the product role requires a strong technical mindset the ability to support and coordinate technical workstreams and effective cross-functional communication skills to support global vaccine manufacturing and continuous improvement initiatives.
Responsibilities
Contribute technical expertise and become a subject matter expert in process and analytics to support end-to-end manufacturing science and technology for LVV products.
Monitor site-specific and cross-site issues help identify trends and participate in the implementation of risk mitigation actions.
Collaborate with functional teams to contribute to strategic workstreams knowledge sharing and process improvement projects. Support projects through all phases including project planning project management and execution.
Provide global technical support for strategic initiatives projects and/or investigations including: authoring of technical documentation process justifications data analysis process monitoring site comparisons and technical risk assessments.
Facilitate technical forums and help maintain product historical knowledge and best practices.
Assist with complex process investigations coordinating and supporting project activities under the guidance of project leads.
Support technical teams and foster strong relationships across the vaccine manufacturing network: build and maintain strong and trusting relationships with site technical operations quality regulatory stability and other stakeholders to ensure effective communication of plans and resolution of issues.
Collaborate with commercialization and internal/external manufacturing sites to enable on-time right-first-time vaccine technology transfers as needed.
Assist in monitoring process performance and participate in data-driven improvement initiatives under the direction of senior team members.
Support preparation of submission packages assist in addressing regulatory technical queries and contribute technical expertise during regulatory inspections as part of a team.
Position Qualifications
B.S. in Chemical Engineering Biochemical Engineering Bioengineering Pharmaceuticals Biochemistry Microbiology or related field plus minimum five (5) years of relevant experience.
Alternatively M.S. with minimum three (3) years of relevant experience or Ph.D. with relevant experience
Required Experience & Skills
Demonstrated problem-solving skills; effective verbal and written communication
Foundational scientific understanding of vaccine and/or biologic products and processes and their effective integration with relevant regulatory/GMP requirements.
Demonstrated leadership experience on projects and/or teams.
Proficiency with pharmaceutical industry technical business processes such as: technical documentntation change control portfolio management risk mitigation deviation management technical protocols/reports and BLA/MAA regulatory license documents.
Strong ability to collaborate and support teams across functional boundaries toward common goals.
Ability to travel up to 10% in support of critical site needs.
Preferred Experience & Skills
Minimum two (2) year in a technical role with direct experience in LVV process or analytics in process development commercialization or manufacturing support.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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U.S. Hybrid Work Model
Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site 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. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The salary range for this role is
$114700.00 - $180500.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Adaptability Deviation Management Engineering Standards Good Manufacturing Practices (GMP) Manufacturing Process Validation Regulatory Compliance Root Cause Analysis (RCA) Strategic Thinking Teamwork Technical Support Technical Transfer Vaccine Development Vaccine Manufacturing Vaccine ProductionPreferred Skills:
Job Posting End Date:
09/20/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Senior IC
Employment Type
Full-Time
