Senior Specialist, Engineering
Senior Specialist, Engineering
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Job Description
Job Description
Durhams Technical Operations Senior Specialist will be an energetic technical leader with strong interpersonal communication and collaboration skills responsible for implementation of technology transfer process knowledge license approval support commercial process enhancement activities and routine support of commercial manufacturing.
This position will primarily support the upstream fermentation and downstream purification processes for the technology transfer of our HPV vaccine drug substance. Additionally this role will contribute to the performance and results of a department provide technical guidance and anticipate and interpret client and/or customer needs to identify and implement solutions. Offshift and weekend coverage will be required based on business unit needs and specific assignments.
The role encompasses technical services support in the areas of equipment and automation systems validation deviation management and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus.
Responsibilities may include but are not limited to:
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.
Actively lead and participate on crossfunctional manufacturing teams to advance project goals and deliverables related to the vaccine process
Lead technical studies and author documentation associated with site commercialization efforts
Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex materialrelated)
Lead structured problem solving for indepth process and equipment investigations
Lead timely resolution of manufacturing disruptions
Collaborate with internal/external partners e.g. Other 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 and lead manufacturing and facility deviations
Author or approve Change Control documentation for complex process validation analytical equipment facility/utility and/or automation changes. Managing ontime implementation and closeout 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 five (5) years of relevant experience; a Master of Science Degree with a minimum of three (3) years of relevant experience; or a Ph.D. with relevant academic experience.
Required Experience and Skills:
Experience in vaccine or biologics manufacturing within a cGMP environment
Experience authoring technical documentation (technical investigations protocols reports or change controls) 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 with culture media and/or buffer formulation processes
Experience with CleaninPlace and SterilizeinPlace systems
Experience with technology transfer methodologies for introduction/launch of a cGMP product
Experience with onthefloor 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 is desired
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
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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.
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
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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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/9/2025*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
