Overview
On Site
$160,000 - $190,000
Full Time
Skills
Biotechnology
Budget
Good Manufacturing Practice
HVAC
Electrical Engineering
Life Sciences
Regulatory Compliance
Manufacturing
Pharmaceutics
cdmo
cGMP
CQV
business operations
Job Details
Position Overview
Lead capital investment initiatives from initial design through operational readiness, delivering compliant, cost-effective infrastructure for pharmaceutical manufacturing environments. This role demands expertise in navigating complex regulatory landscapes while orchestrating multi-disciplinary teams across facility buildouts and process installations.
Primary Accountabilities
Project Delivery & Execution
- Orchestrate comprehensive project roadmaps spanning concept, engineering, construction, and facility validation phases to achieve on-time, on-budget delivery
- Oversee financial planning and expenditure tracking, implementing corrective actions when budget variances arise
- Drive continuous project surveillance to preemptively identify obstacles and deploy solutions
Regulatory & Quality Assurance
- Uphold rigorous safety, quality, and regulatory compliance aligned with company standards and health authority mandates (FDA, EMA, etc.)
- Maintain adherence to all applicable legal frameworks and industry regulations throughout project lifecycle
- Leverage contemporary commissioning, qualification, and validation (CQV) methodologies to accelerate facility readiness without compromising compliance integrity
Team Leadership & Collaboration
- Facilitate seamless coordination among cross-functional project contributors to ensure unified execution
- Provide leadership, professional development, and guidance to team members regardless of reporting structure
- Cultivate productive partnerships with external suppliers and construction firms to secure superior deliverables and punctual completion
Strategic Communication & Risk Oversight
- Deliver comprehensive project briefings to stakeholders and executive leadership, including formal presentations at governance forums
- Proactively assess project vulnerabilities and architect mitigation frameworks
- Allocate and optimize project assets including capital equipment, raw materials, and human resources
Candidate Qualifications
Educational Foundation
- Undergraduate degree in Chemical, Mechanical, Electrical Engineering, or equivalent technical discipline
Professional Experience
- Substantial background managing engineering projects within pharmaceutical, biotechnology, or chemical manufacturing sectors
- Demonstrated success in budget stewardship and timeline management for capital infrastructure investments
- Deep operational understanding of contract development and manufacturing organization (CDMO) business models, engineering operations, and current Good Manufacturing Practice (cGMP) for small molecule and biologic active pharmaceutical ingredients
Technical Proficiency
- Comprehensive knowledge across life sciences engineering domains: utility systems (purified water, HVAC), process equipment, automation/control systems, instrumentation, and facilities infrastructure
- Competency with standard business software platforms: Microsoft Office Suite (Word, Excel, PowerPoint) and diagramming tools (Visio)
- Familiarity with progressive CQV strategies that compress construction-to-production transitions while preserving regulatory compliance
Additional Capabilities
- Spanish language fluency strongly advantageous
- Ability to navigate matrix organizational structures and influence without formal authority
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.