Senior Project Engineer; RadioPharma

Overview

Senior Project Engineer – Rochester, MN (onsite)

• Responsible for leading and executing capital and construction projects
• Serve as the primary liaison for contractors, vendors, and equipment providers, ensuring projects are delivered on time, within budget, and to the highest safety and quality standards
• Play a critical role in building and scaling facilities, fostering a strong on-site culture of safety and compliance, and establishing accountability frameworks with external partners
• Must have cGMP technical expertise, strong leadership, and a collaborative approach to managing cross-functional teams and external stakeholders
• Lead planning, execution, and delivery of large-scale capital projects with a focus on radiopharmaceutical facility design, construction, and GMP-compliant commissioning
• Ensure all projects meet stringent FDA, EMA, and Annex 1 regulatory requirements, including aseptic processing, controlled environments, cleanroom classifications, radiation shielding, and specialized facility infrastructure, dependent on the site needs and phase
• Oversee design and installation of process equipment specific to operations (hot cells, isolators, synthesis units, automated dispensing and packaging systems) to ensure compliance with cGMP, radiation safety, and sterile manufacturing standards
• Develop and manage commissioning, qualification, and validation (CQV) strategies, including IQ/OQ/PQ protocols, to verify facility, equipment, and utilities performance and ensure operational readiness
• Partner cross-functionally with Quality, Regulatory, and EHS teams to integrate radiation safety culture, contamination control strategies, and ALARA principles into all phases of capital project execution
• Drive continuous improvement in facility design and project delivery by incorporating emerging technologies, automation, and digital monitoring tools to support reliable, safe, and efficient manufacturing, deliver and communicate metrics/dashboards on a weekly basis
• Serve as the primary technical and operational liaison for all contractors, vendors, and external partners engaged in facility design, construction, process equipment installation, and commissioning
• Establish and enforce detailed project execution plans, with clearly defined scope, deliverables, and timelines, supported by measurable KPIs and accountability metrics for safety, quality, regulatory compliance, and cost adherence
• Review and approve contractor submittals including safety programs, radiation protection protocols, quality control procedures, CQV documentation, and regulatory compliance plans to ensure alignment with cGMP, FDA, NRC, and Annex 1 standards
• Conduct regular performance reviews, audits, and inspections to validate contractor and vendor compliance with project specifications, safety culture expectations (including ALARA principles), and contractual obligations
• Foster strong, collaborative working relationships with contractors and suppliers while maintaining the ability to escalate and enforce accountability when performance, compliance, or safety standards are not met
• Drive vendor performance improvement by incorporating scorecards, lessons learned, and continuous improvement initiatives into ongoing and future capital projects
• Champion a culture of safety across all project activities, ensuring that contractors, vendors, and team members follow best-in-class safety practices
• Conduct routine site safety inspections and audits, taking corrective action where needed
• Ensure compliance with FDA, NRC, cGMP, OSHA, and environmental regulations applicable to operations
• Manage all aspects of project delivery, including schedules, budgets, risk assessments, and mitigation strategies
• Review and analyze contractor submittals, technical documents, and project plans for compliance, feasibility, and alignment with goals
• Provide leadership updates on project progress, risks, and outcomes in a clear and timely manner
• Develop and maintain Standard Operating Procedures (SOPs) and documentation supporting project execution
• Work closely with internal stakeholders including engineering, maintenance, quality, and leadership to ensure…