Filling Process SME

Blackfield Associates are currently partnered with a global pharmaceutical manufacturer to support their search for a Filling Process SME to join their project based in North Carolina on an initial 12-month contract. Key Responsibilities Lead the design, implementation, and start-up of aseptic filling systems for vial and prefilled syringe manufacturing operations. Develop and approve key engineering deliverables including user requirements specifications, process flow diagrams, equipment specifications, and technical documentation. Lead equipment selection activities, including vendor evaluations, technical assessments, and bid reviews. Oversee the detailed design, integration, and installation of filling lines, isolators, E-Beam systems, and associated aseptic processing equipment. Ensure filling systems are designed and implemented in compliance with cGMP requirements, Annex 1 guidance, and contamination control principles. Serve as the technical lead for Factory Acceptance Testing, Site Acceptance Testing, Commissioning, Qualification, and start-up activities. Drive technical issue resolution during installation, commissioning, qualification, and operational readiness phases. Coordinate with Manufacturing, MSAT, Quality, Facilities, Procurement, Engineering, and EHS teams to ensure successful project execution. Manage relationships with equipment suppliers, engineering firms, and construction contractors to ensure delivery of project objectives. Support facility and equipment readiness for qualification and commercial manufacturing operations. Monitor industry trends, emerging technologies, and regulatory developments to drive continuous improvement and innovation in aseptic filling operations. Ensure project activities are delivered safely, compliantly, and in alignment with quality, schedule, and business objectives. Experience Required Bachelor's degree in Engineering, preferably Mechanical Engineering. Advanced degree is advantageous. Minimum 10 years of experience supporting aseptic filling systems within pharmaceutical or biopharmaceutical manufacturing environments. Proven experience serving as a technical lead or subject matter expert for sterile injectable manufacturing operations. Hands-on experience with the design, installation, commissioning, qualification, and start-up of aseptic filling lines, including isolator-based technologies. Strong knowledge of vial and prefilled syringe filling systems for biologics manufacturing. Deep understanding of aseptic processing principles, contamination control strategies, FDA cGMP requirements, and EU Annex 1 regulations. Experience delivering large-scale capital projects involving aseptic manufacturing facilities and equipment. Strong background working with equipment vendors, engineering contractors, and multidisciplinary project teams. Knowledge of commissioning and qualification methodologies, facility design, procurement processes, project controls, and construction execution. Excellent technical problem-solving, leadership, communication, and stakeholder management skills. Experience supporting greenfield or brownfield manufacturing facility projects is highly desirable. Previous involvement in projects valued between 50M-100M and transitioning systems from design through commercial operation is preferred. #J-18808-Ljbffr Blackfield Associates