Project Executive (Life Sciences)
On-siteDurham, North Carolina, United States
Durham, North Carolina, United StatesOn-sitePart TimeSenior LevelSmall
Part TimeSenior LevelSmall
Job Summary
Oversee and direct life science capital projects from conception to completion, developing execution strategies, logistics plans, and safety protocols with clients and general contractors. Prepare construction budgets, manage detailed schedules, and conduct site walkthroughs to ensure compliance with FDA regulations, cGMP standards, and project scope. Monitor budget, schedule, and quality performance while managing contracts with contractors and consultants. Prepare comprehensive reports on project status, financial health, and risks for senior leadership and stakeholders. This full-time, permanent position alternates between our Durham, NC HQ and client locations, requiring valid driver's license and on-site safety gear. We offer a competitive benefits package including 401k, full medical/dental/vision, and paid time-off.
Required Qualifications
- 15-20 years of experience in managing complex life science capital projects
- demonstrated expertise in stakeholder management
- demonstrated expertise in strategic planning
- demonstrated expertise in cross-functional leadership
- Bachelor's degree in engineering, construction management, facilities management, or a related technical field
- equivalent experience
- Proven track record in managing large-scale projects (>$20M) within the life science sector
- Substantial experience with cGMP facility design, build, qualification, and maintenance
- Experience with the design, construction, commissioning, and operation of pharmaceutical, biotechnology, and/or general life sciences facilities and infrastructure
- Experienced leader
- knowledge of program management
- knowledge of project management
- knowledge of project controls
- knowledge of construction management
- knowledge of commissioning
- knowledge of qualification services in regulated environments
- Strong experience in project budgeting, scoping, and estimating
- managing capital project financials
- Proven ability to lead cross-functional teams
- ability to build strong stakeholder relationships
- ability to manage multiple high-priority projects simultaneously
- Strong interpersonal skills
- ability to influence stakeholders
- ability to manage conflicts
- ability to build consensus
- Exceptional communication skills
- ability to present data clearly and concisely to senior leaders and stakeholders
- Experience working on regulated industries
- knowledge of regulatory and compliance requirements: FDA regulations
- knowledge of Good Engineering Practices (GEP)
- knowledge of current Good Manufacturing Practices (cGMP)
- knowledge of Good Documentation Practices (GDP)
- Familiarity with the Code of Federal Regulations (CFR) as related to cGMP in Manufacturing, Processing, Packaging, and Holding of Drugs and Finished Pharmaceuticals
- Familiarity with the Code of Federal Regulations (CFR) as related to Dietary Supplement & Human Food
- Familiarity with the Code of Federal Regulations (CFR) as related to Biological Products & General Biological Products Standards
- Familiarity with the Code of Federal Regulations (CFR) as related to Good Clinical Practices for Medical Devices
- Familiarity with the Code of Federal Regulations (CFR) as related to Quality Systems Regulations
- Previous project experience in one or more of the following technologies and platforms: manufacturing and utilities systems
- Previous project experience in one or more of the following technologies and platforms: clean and aseptic rooms
- Previous project experience in one or more of the following technologies and platforms: clean-in-place (CIP)
- Previous project experience in one or more of the following technologies and platforms: steam-in-place (SIP)
- Previous project experience in one or more of the following technologies and platforms: autoclaves
- Previous project experience in one or more of the following technologies and platforms: vapor hydrogen peroxide (VHP) sterilization
- Previous project experience in one or more of the following technologies and platforms: solid dose preparation areas
- Previous project experience in one or more of the following technologies and platforms: powder feeding and continuous manufacturing
- Previous project experience in one or more of the following technologies and platforms: blending, milling, granulation, and formulation
- Previous project experience in one or more of the following technologies and platforms: fermentation, purification, and conjugation processes
- Previous project experience in one or more of the following technologies and platforms: controlled temperature environments
- Previous project experience in one or more of the following technologies and platforms: injectables sterile fill and packaging facilities
- Previous project experience in one or more of the following technologies and platforms: conveyors and clean packaging automation
- Previous project experience in one or more of the following technologies and platforms: GMP warehousing
- Previous project experience in one or more of the following technologies and platforms: automated storage and retrieval warehouse systems
- The job requires both office and site-based work
- travel to job sites in various weather conditions
- On-site safety gear (e.g., hard hat, glasses, safety harness)
- Ability to traverse construction sites and perform inspections in various weather conditions
- May involve lifting up to 30 lbs
- extended periods of sitting or using office equipment
- May require travel
- Must have valid driver's license
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