Fill-Finish Subject Matter Expert (SME)

Fill-Finish Subject Matter Expert (SME) Job Location:- Beloit, Wisconsin- Day 1 Onsite (Candidate needs to work 4 Days at the Client Office) Job Type: Contract Job Duration: Long Term. Client is seeking an experienced Fill-Finish Subject Matter Expert (SME) to support the commissioning and start-up of a new GMP-compliant fill-finish facility for radiopharmaceutical products. This role will be critical in ensuring that the facility and operations meet regulatory standards and are prepared for full-scale production of sterile injectable products. The ideal candidate will have a strong background in GMP manufacturing, sterile processing, and regulatory compliance within the pharmaceutical or radiopharmaceutical industry. Key Responsibilities • Facility Preparation & Commissioning: o Serve as the technical expert in the design, commissioning, and qualification of the fill-finish facility and equipment. o Collaborate with engineering and validation teams to ensure compliance with GMP, FDA, and other global regulatory standards. o Support the qualification and validation of clean rooms, HVAC systems, and sterile equipment. Process Development & Optimization: o Consult on development, scale-up, and optimization of fill-finish processes for radiopharmaceuticals, including aseptic filling, capping, sealing, and inspection. o Establish and optimize standard operating procedures (SOPs) for fill-finish processes in line with GMP requirements. o Support troubleshooting and continuous improvement initiatives for manufacturing processes. GMP Compliance & Documentation: o Ensure all fill-finish operations meet GMP guidelines and regulatory standards (e.g., FDA, EMA, ICH). o Develop and review batch records, validation protocols, and reports for all fill-finish activities. o Lead the preparation for GMP audits and inspections, working closely with the Quality Assurance (QA) team. Cross-Functional Collaboration: o Collaborate with R&D, Engineering, Validation, Quality, and Regulatory Affairs teams to ensure the seamless transition from facility build-out to production readiness. o Interface with external vendors and suppliers for equipment procurement, validation, and ongoing maintenance. Skillsets Required • Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field. Advanced degree preferred. • Minimum of 8 years of experience in fill-finish operations within a GMP-regulated pharmaceutical or biopharmaceutical environment, with a focus on sterile injectables or radiopharmaceuticals. • Proven experience in facility commissioning, process validation, and technology transfer in a GMP environment. • Strong knowledge of regulatory guidelines (FDA, EMA, ICH) and aseptic processing requirements. • Excellent problem-solving, project management, and communication skills. • Ability to work cross-functionally and lead teams in a highly regulated environment. • Experience with radiopharmaceutical products. • Knowledge of cGMPs for the production of sterile pharmaceuticals and radiopharmaceuticals. • Experience with quality systems, risk management, and regulatory submissions.