SciPro
Senior Engineering Manager (Facilities & Construction)
SciPro, Saint Paul, Minnesota, United States
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This range is provided by SciPro. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $110,000.00/yr - $150,000.00/yr
Direct message the job poster from SciPro
Placing the top Medical Device talent in the U.S PRINCIPAL RESPONSIBILITIES Capital Projects & RadioPharma Facility Development
Lead the planning, design, construction, and commissioning of capital projects for radiopharmaceutical facilities.
Ensure facilities and systems comply with FDA, EMA, Annex 1, cGMP, radiation safety, and aseptic processing requirements.
Oversee the design, installation, and qualification of RadioPharma equipment such as hot cells, isolators, synthesis units, and automated dispensing/packaging systems.
Develop and manage CQV strategies (IQ/OQ/PQ) to ensure equipment, utilities, and facilities are fully qualified and ready for production.
Partner with Quality, Regulatory, and EHS to integrate radiation safety, contamination control, and ALARA principles into all project phases.
Drive continuous improvement in project execution by leveraging new technologies, automation, and digital monitoring tools; provide regular project metrics and dashboards.
Serve as the primary technical liaison for contractors, vendors, and external partners.
Define scope, deliverables, timelines, and KPIs to ensure safe, compliant, and cost-effective project execution.
Review and approve contractor safety plans, regulatory compliance documentation, and CQV deliverables.
Conduct regular audits, inspections, and performance reviews to ensure adherence to project standards and regulatory requirements.
Maintain strong vendor relationships while enforcing accountability when performance or compliance issues arise.
Implement scorecards, lessons learned, and improvement initiatives to strengthen vendor performance.
Safety & Compliance
Promote a strong safety culture across all project activities.
Conduct routine safety inspections and ensure corrective actions are completed.
Ensure compliance with FDA, NRC, cGMP, OSHA, and environmental requirements for RadioPharma operations.
Manage project schedules, budgets, risks, and mitigation strategies from planning through delivery.
Review technical documents and contractor submittals for accuracy, feasibility, and compliance.
Provide leadership with clear updates on project status, risks, and milestones.
Develop and maintain SOPs and project execution documentation.
Cross-Functional Collaboration & Communication
Partner closely with engineering, maintenance, quality, and site leadership to align on objectives and deliverables.
Host site tours, meetings, and presentations for leadership, customers, and external stakeholders.
Prepare routine project reports summarizing progress, risks, and next steps.
Recommend technical and process improvements to enhance facility efficiency and reliability.
Support knowledge sharing and organizational learning to strengthen engineering and project management capabilities.
QUALIFICATIONS & EXPERIENCE
Bachelor’s degree in Civil, Structural, Mechanical, or related Engineering, or equivalent experience; advanced degree is a plus.
PE license or comparable state certification preferred.
Required experience with Lean Six Sigma and program management.
8+ years leading capital projects in regulated industries; RadioPharma, Biopharma, or other cGMP experience strongly preferred.
Strong background in construction management, contractor coordination, and vendor oversight.
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.
Effective leader with strong communication and interpersonal skills; capable of building trust and making data-driven decisions.
Strong process management abilities to support reliable and efficient cGMP operations.
Proven collaborator who can align diverse teams and ensure vendor accountability with a patient-first approach.
Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced environment.
Flexible and willing to work extended hours, shifts, or weekends as project needs arise.
Willing to travel up to 20% to support other locations.
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Engineering and Project Management
Industries:
Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at SciPro by 2x
401(k)
Medical insurance
Vision insurance
#J-18808-Ljbffr
Get AI-powered advice on this job and more exclusive features.
This range is provided by SciPro. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $110,000.00/yr - $150,000.00/yr
Direct message the job poster from SciPro
Placing the top Medical Device talent in the U.S PRINCIPAL RESPONSIBILITIES Capital Projects & RadioPharma Facility Development
Lead the planning, design, construction, and commissioning of capital projects for radiopharmaceutical facilities.
Ensure facilities and systems comply with FDA, EMA, Annex 1, cGMP, radiation safety, and aseptic processing requirements.
Oversee the design, installation, and qualification of RadioPharma equipment such as hot cells, isolators, synthesis units, and automated dispensing/packaging systems.
Develop and manage CQV strategies (IQ/OQ/PQ) to ensure equipment, utilities, and facilities are fully qualified and ready for production.
Partner with Quality, Regulatory, and EHS to integrate radiation safety, contamination control, and ALARA principles into all project phases.
Drive continuous improvement in project execution by leveraging new technologies, automation, and digital monitoring tools; provide regular project metrics and dashboards.
Serve as the primary technical liaison for contractors, vendors, and external partners.
Define scope, deliverables, timelines, and KPIs to ensure safe, compliant, and cost-effective project execution.
Review and approve contractor safety plans, regulatory compliance documentation, and CQV deliverables.
Conduct regular audits, inspections, and performance reviews to ensure adherence to project standards and regulatory requirements.
Maintain strong vendor relationships while enforcing accountability when performance or compliance issues arise.
Implement scorecards, lessons learned, and improvement initiatives to strengthen vendor performance.
Safety & Compliance
Promote a strong safety culture across all project activities.
Conduct routine safety inspections and ensure corrective actions are completed.
Ensure compliance with FDA, NRC, cGMP, OSHA, and environmental requirements for RadioPharma operations.
Manage project schedules, budgets, risks, and mitigation strategies from planning through delivery.
Review technical documents and contractor submittals for accuracy, feasibility, and compliance.
Provide leadership with clear updates on project status, risks, and milestones.
Develop and maintain SOPs and project execution documentation.
Cross-Functional Collaboration & Communication
Partner closely with engineering, maintenance, quality, and site leadership to align on objectives and deliverables.
Host site tours, meetings, and presentations for leadership, customers, and external stakeholders.
Prepare routine project reports summarizing progress, risks, and next steps.
Recommend technical and process improvements to enhance facility efficiency and reliability.
Support knowledge sharing and organizational learning to strengthen engineering and project management capabilities.
QUALIFICATIONS & EXPERIENCE
Bachelor’s degree in Civil, Structural, Mechanical, or related Engineering, or equivalent experience; advanced degree is a plus.
PE license or comparable state certification preferred.
Required experience with Lean Six Sigma and program management.
8+ years leading capital projects in regulated industries; RadioPharma, Biopharma, or other cGMP experience strongly preferred.
Strong background in construction management, contractor coordination, and vendor oversight.
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.
Effective leader with strong communication and interpersonal skills; capable of building trust and making data-driven decisions.
Strong process management abilities to support reliable and efficient cGMP operations.
Proven collaborator who can align diverse teams and ensure vendor accountability with a patient-first approach.
Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced environment.
Flexible and willing to work extended hours, shifts, or weekends as project needs arise.
Willing to travel up to 20% to support other locations.
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Engineering and Project Management
Industries:
Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at SciPro by 2x
401(k)
Medical insurance
Vision insurance
#J-18808-Ljbffr