Senior Project Engineer

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The Senior Project Engineer is responsible for leading and executing capital and construction projects that directly support Nucleus RadioPharma's mission. This role serves 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. The Senior Project Engineer will play a critical role in building and scaling RadioPharma facilities, fostering a strong on-site culture of safety and compliance, and establishing accountability frameworks with external partners. This position requires cGMP technical expertise, strong leadership, and a collaborative approach to managing cross-functional teams and external stakeholders.

About Nucleus RadioPharma, Inc.

Nucleus RadioPharma is driving the market for precision radiopharmaceuticals forward by collaborating with and guiding innovative companies through the complexities of developing, manufacturing, and delivering breakthrough radiotherapies. We bridge the gap between scientific potential and real-world application, ensuring that companies can make their life-saving treatments a reality and patients receive timely, cutting-edge care. We believe in a future where these groundbreaking therapies, rooted in minimal invasiveness and maximum efficacy, are accessible. By transforming the treatment landscape with our trusted expertise and comprehensive approach, we're not just fighting cancer-we're redefining the battle itself.

Description

PRINCIPAL RESPONSIBILITIES

Capital Projects & RadioPharma Facility Development

• 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

Contractor & Vendor Management

• 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

Safety & Compliance

• 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

Project Leadership & Execution

• 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

Cross-functional Collaboration & Communication

• 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

Continuous Improvement & Innovation

• 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

QUALIFICATIONS & EXPERIENCE

• Bachelor's degree in Civil, Structural, Mechanical, or related Engineering required, or equivalent experience; advanced degree a plus.
• Professional Engineer (PE) license or equivalent state-issued certification preferred.
• Lean Six Sigma, program Management experience required.
• 8+ years of relevant experience managing capital projects in regulated industries; prior experience in RadioPharma, Biopharma, or related cGMP environment strongly preferred.
• 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

THE FINE PRINT:

The salary range for this position is $110,000 - $150,000 per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate's qualifications, skills, competencies, experience, and location.

Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation is available to qualified team members.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains "at-will".

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

Salary

$110,000 - $150,000 per year