Specialist, Engineering USA - North Carolina - Durham (Old Oxford)-2

Merck & Co. • Durham, NC

291d • Onsite

About The Position

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 1,000+ people. Durham's Technology Transfer Senior 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.

Requirements

• 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.
• 2 years' relevant experience.
• 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.

Nice To Haves

• 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 (e.g.FDA, EMA).
• Experience with face to face presentation of technically complex subjects to regulatory inspectors.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree