SciPro ยท 2 weeks ago
Senior Engineering Manager (Facilities & Construction)
SciPro is a company focused on radiopharmaceutical facility projects, and they are seeking a Senior Engineering Manager to lead the planning, design, and construction of these facilities. The role involves ensuring compliance with safety and regulatory standards, managing contractor relationships, and overseeing project execution from start to finish.
Responsibilities
Lead the planning, design, construction, and startup of radiopharmaceutical facility projects
Ensure buildings, equipment, and systems meet FDA, EMA, Annex 1, cGMP, radiation safety, and aseptic standards
Oversee the design, installation, and qualification of RadioPharma equipment (hot cells, isolators, synthesis units, automated dispensing/packaging systems)
Create and manage commissioning and qualification plans (IQ/OQ/PQ) for equipment, utilities, and facilities
Act as the main technical contact for contractors, vendors, and external partners
Define project scope, deliverables, timelines, and KPIs to ensure safe, compliant, and cost-effective work
Approve contractor safety plans, compliance documents, and qualification packages
Build strong vendor relationships while holding teams accountable for performance
Promote strong safety practices across all project work
Maintain compliance with FDA, NRC, cGMP, OSHA, and environmental regulations
Suggest improvements to enhance facility performance, efficiency, and reliability
Manage schedules, budgets, risks, and mitigation plans from project start to finish
Review technical documents and contractor submittals for accuracy and compliance
Provide leadership with clear updates on progress, risks, and key milestones
Develop and maintain SOPs
Work closely with engineering, maintenance, quality, and site leadership to align on goals
Lead site tours, meetings, and presentations for leaders, customers, and external partners
Qualification
Required
Bachelor's degree in Civil, Structural, Mechanical, or related Engineering, or equivalent experience
8+ years leading capital projects in regulated industries
Strong background in construction management, contractor coordination, and vendor oversight
Required experience with Lean Six Sigma and program management
Skilled at setting performance goals, tracking progress, and holding contractors accountable while maintaining positive partnerships
Deep understanding of cGMP, OSHA, NRC, and FDA safety and compliance requirements
Proficient in CAD software, project management tools, and Microsoft Office
Flexible and willing to work extended hours, shifts, or weekends as project needs arise
Willing to travel up to 20% to support other locations
Preferred
advanced degree is a plus
RadioPharma, Biopharma, or other cGMP experience strongly preferred
PE license or comparable state certification preferred
Company
SciPro
SciPro is a staffing agency specializing in the life sciences field and offers regulatory affairs, biometrics, and clinical operations jobs.
Funding
Current Stage
Early StageCompany data provided by crunchbase