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.

• 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.

• 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.