Specialist, Engineering
Specialist, Engineering
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Job Description
Job Description
The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham NC. This state-of-the-art facility established in 2004 manufactures our Company lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company Vaccine Manufacturing network the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1000 people.
Durhams Technology Transfer Specialist will be an energetic technical leader with strong interpersonal communication and collaboration skills responsible for implementation of technology transfer process knowledge post approval support and post commercial process enhancements activities for pipeline vaccine programs. This is position will support vaccine drug substance site readiness and technology transfer focusing on either upstream downstream and/or culture media/support systems.
Off-shift and weekend coverage will be required based on business unit needs and specific assignments.
Responsibilities may include but are not limited to:
Travel 25% of the time
Provide technical/team support and leadership for commercial technology transfer and qualification studies associated with the development and implementation of processes systems and facilities related to vaccine drug substance and key intermediates e.g. buffers media and cleaning solutions.
Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process
Lead technical studies and author documentation associated with site commercialization efforts
Participate in the equipment specification selection/procurement and qualification phases of vaccine capital projects
Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related)
Collaborate with internal/external partners e.g. Our Company sites Procurement Raw Material & Component Suppliers
Develop effective data analytics methodologies including statistical process control deepening process understanding
Author review and/or edit technical documents to support regulatory filings including technical reports and risk assessments
Author or approve Change Control documentation for complex process validation analytical equipment facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project production and supply timelines.
Lead aspects of regulatory inspections by presenting and defending technical documentation investigations and change controls
Evaluate and develop innovative process technologies continuous process improvements and post launch process enhancements
Provide post approval support and subject matter expertise support to ongoing manufacturing activities.
Education Minimum Requirement:
Bachelor of Science Degree in Chemical Engineering Biochemical Engineering Bioengineering or related life science field with a minimum of two (2) years of relevant experience or a Master of Science Degree.
Required Experience and Skills:
Experience in vaccine or biologics manufacturing within a cGMP environment
Experience authoring technical documentation within a cGMP context
Proven leader with influence and outstanding communication (written & presentation) skills
Experience with project strategic plan development and management
Ability to foster a collaborative work environment focused on mentorship coaching and Subject Matter Expert development
Preferred Experience and Skills:
Experience in bulk upstream and/or downstream vaccine processes within a cGMP environment
Experience in manufacturing support processes including media development/manufacture and/or single-use component design and qualification
Experience with technology transfer methodologies for introduction/launch of a cGMP product
Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions
Authored complex process change control
Authored complex deviation investigations
Experience with validation documentation and execution
Experience with SAP
Experience with Manufacturing Execution Systems (MES)
Experience with Delta V
Ability to provide scientific mentorship and guidance to technical colleagues
Ability to read Piping and Instrumentation Diagrams
Lean Six Sigma belt certification
Experience with process risk assessment tools
Experience with responding to regulatory questions with multiple agencies ( EMA)
Experience with face to face presentation of technically complex subjects to regulatory inspectors
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.
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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
$85600.00 - $134800.00This 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:
Domestic/InternationalVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Adaptability Adaptability Biodesign Capital Projects Change Control Management Chemical Engineering Collaborative Communications Data Analysis Equipment Troubleshooting Good Manufacturing Practices (GMP) Lean Manufacturing Manufacturing Support Personal Initiative Process Innovation Process Optimization Professional Integrity Project Management Regulatory Inspections Risk Control Assessment Root Cause Analysis (RCA) SAP PP (Production Planning) Six Sigma Strategic Planning Technical Writing Technology Transfer 1 morePreferred Skills:
Job Posting End Date:
07/30/2025*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:
Unclear Seniority
Employment Type
Full-Time
