Nucleus RadioPharma · 1 day ago
Senior Project Engineer
Rochester, MN
Full-time
Onsite
Senior Level, Lead/Staff
$110K/yr - $150K/yr
8+ years expNucleus RadioPharma is focused on delivering innovative solutions in the radiopharmaceutical sector, and they are seeking a Senior Project Engineer to lead capital and construction projects. This role involves managing project execution, ensuring compliance with safety and quality standards, and collaborating with contractors and vendors to deliver successful outcomes.
Health Care
Responsibilities
Lead planning, execution, and delivery of large-scale capital projects with a focus on radiopharmaceutical (RadioPharma) 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 RadioPharma 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 RadioPharma 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 RadioPharma 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 RadioPharma 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 alignment of project objectives and deliverables
Host site visits, tours and provide presentations to leadership, customers, and external stakeholders as needed
Produce regular project status reports, highlighting key achievements, risks, and next steps
Recommend process and technical design improvements to enhance facility performance, efficiency, and reliability
Actively contribute to knowledge sharing and organizational learning to strengthen engineering and project delivery capabilities
Qualification
Required
Bachelor's degree in Civil, Structural, Mechanical, or related Engineering required, or equivalent experience; advanced degree a plus
Lean Six Sigma, program Management experience required
8+ years of relevant experience managing capital projects in regulated industries
Demonstrated expertise in construction project management, contractor oversight, and vendor performance management
Proven ability to establish metrics, track performance, and hold contractors accountable while maintaining collaborative relationships
In-depth knowledge of safety and compliance standards including cGMP, OSHA, NRC, and FDA regulations
Proficiency with CAD software, project management platforms, and Microsoft Office Suite
Strong leadership, communication, and interpersonal skills with the ability to build trust and make data driven decisions
Strong Process Management skills ensuring process flows, work processes deliver results now and in the future for cGMP operations
Strong collaboration skills with the ability to hold vendor accountability, proven experience driving alignment across diverse stakeholders always having the patient in mind
Highly organized, analytical, and detail-oriented with the ability to manage multiple priorities in a fast-paced environment
Willingness to work extended hours, shifts, and weekends when required to meet project demands
Willingness to travel up to 20%, as needed to other sites
Preferred
Professional Engineer (PE) license or equivalent state-issued certification
Prior experience in RadioPharma, Biopharma, or related cGMP environment
Benefits
Medical, dental, and vision insurance
Health Savings Account or Flexible Spending Account options
401k retirement account access with employer matching
Paid sick leave and/or other paid time off in compliance with applicable law
Relocation is available to qualified team members
Company
Nucleus RadioPharma
Nucleus RadioPharma is a new company built to ensure cancer patients can access potentially life-saving radiopharmaceuticals.
11-50 employees
H1B Sponsorship
Nucleus RadioPharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
Funding
Current Stage
Early StageTotal Funding
$62M2024-06-05Series A
2023-10-17Series A· $56M
2022-10-12Seed· $6M
Leadership Team
Stephen Hahn
Chief Executive Officer
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