Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Durham’s Technology 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 primarily support vaccine drug substance site readiness and technology transfer.
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. Off-shift 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 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. Other Merck 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 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.
- 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 Engineering or Life Sciences
Required Experience and Skills:
- Two (2) years of relevant experience or a Master of Science Degree.
- Experience in vaccine or biologics manufacturing
- Experience authoring technical documentation
- 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
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 Clean-in-Place and Sterilize-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
- 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 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 (e.g.FDA, EMA)
- Experience with face to face presentation of technically complex subjects to regulatory inspectors
- Advanced degree (MS) in science or engineering
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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