Specialist, Engineering

Job Description

Durham's 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 enhancement activities for pipeline vaccine programs.

This position will primarily support the downstream purification process for the technology transfer of our Company's HPV vaccine drug substance. Additionally, this role will support future upstream fermentation and aluminum adjuvant manufacturing processes. The individual will contribute to the performance and results of a department, provide technical guidance, and on floor support of automation and processing excursions. This role will include shift and weekend coverage as required to support continuous manufacturing.

The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise.

Travel: 5% of the time

Responsibilities may include but are not limited to:

• Provide technical/team support on the production floor 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
• Respond to process automation holds and alarms working cross-functionally with operations and quality.
• Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to the vaccine process
• Support technical studies and author documentation associated with site commercialization efforts
• Provide knowledge for manufacturing investigations support (Product and process deviations and complex material-related events)
• Collaborate with internal/external partners, e.g. Other Company sites, Global Teams, Procurement, Raw Material & Component Suppliers
• Develop effective data analytics methodologies, including statistical process control, and deepening process understanding
• Author, review, and/or edit technical documents to support regulatory filings including technical protocols, reports and risk assessments
• Manage on-time implementation and close-out to meet project, production and supply timelines.
• Support 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
• Demonstrated systematic problem-solving skills
• Proven leader with influence and outstanding communication skills
• Ability to foster a collaborative work environment
• 12 hour rotating shifts, 2-2-3 schedule days/nights including weekends and holidays.

Preferred Experience and Skills:

• Experience authoring technical documentation (technical investigations, protocols, reports, or change controls) within a cGMP context.
• Experience in bulk downstream vaccine or protein purification processes within a cGMP environment
• Experience with chromatography separation technologies or chromatography column packing/unpacking
• Experience with homogenization, microfiltration or ultrafiltration technologies
• Experience with analytical assays; including liquid chromatography, UV-Vis
• Experience with SAP, Manufacturing Execution Systems (MES), DeltaV
• Experience with Clean-in-Place and Sterilize/Sanitize-in-Place systems
• 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 or deviation investigations
• Experience with validation documentation and execution
• Ability to read Piping and Instrumentation Diagrams is desired
• Lean Six Sigma belt certification
• Experience with process risk assessment tools
• Experience with face-to-face presentation of technically complex subjects to regulatory inspectors or responding to regulatory questions with multiple agencies (e.g.FDA, EMA)

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. VETJOBS #EBRG

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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, generally Tuesday, Wednesday and either Monday or 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 presence. 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. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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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 pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:08/21/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R307053