Specialist, Engineering

Technology Transfer Specialist

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

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 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 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:

• 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)
• Authoring deviation investigations
• 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 shop floor hypercare supporting during manufacturing
• 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 manufacturing support processes including weigh and dispense, media/buffer, and sterile supply
• Experience with single-use component 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

Required Skills:

• Adaptability, Biodesign, Change Control Management, Chemical Engineering, Collaborative Communications, Continuous Process Improvement, Data Analysis, Equipment Troubleshooting, Good Manufacturing Practices (GMP), Lean Manufacturing, Manufacturing Support, Personal Initiative, Process Innovation, Process Optimization, Process Technologies, Procurement, Professional Integrity, Project Management, Risk Control Assessment, Root Cause Analysis (RCA), Strategic Procurement, Technical Writing, Technology Transfer, Vaccine Manufacturing

Preferred Skills:

• 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.

The salary range for this role is $85,600.00 - $134,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's 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.