Senior Project Engineer
Listed on 2026-07-27
-
Engineering
Quality Engineering, Validation Engineer, Regulatory Compliance Specialist, Pharma Engineer
Location: 3050 Spruce Street, Saint Louis, Missouri
Introduction
:
We are seeking a highly skilled and experienced Principal Project Enginee
r to lead and oversee complex engineering projects that drive innovation and operational excellence within our organization. This pivotal role requires a strategic thinker with strong technical expertise and leadership capabilities to ensure projects are delivered on time, within scope, and budget, while meeting the highest quality standards. The Principal Project Engineer will collaborate across multidisciplinary teams, influence stakeholders, and contribute to the continuous improvement of engineering processes and capital project executio
n methodologies, playing a critical role in advancing our organizational goals
.
Key Responsibilities- Lead engineering activities for pharmaceutical capital projects.
- Provide technical guidance throughout design, construction, commissioning, and validation.
- Collaborate with engineering, construction, project management, and operations teams.
- Review engineering drawings, P&IDs, RFIs, contractor submittals, and construction documentation.
- Support cleanroom construction, facility expansion, qualification, and validation.
- Ensure compliance with GMP/cGMP standards and quality requirements.
- Manage project scope, schedule, budget, risks, and documentation.
- Conduct field quality inspections and document observations and corrective actions.
- Communicate project updates and drive technical decisions with stakeholders.
- Bachelor's degree in Engineering (Process Engineering preferred).
- 15+ years of engineering experience supporting pharmaceutical capital projects.
- Strong pharmaceutical manufacturing and GMP/cGMP experience.
- Hands-on experience with cleanroom construction
, commissioning, qualification, and validation. - Experience reviewing engineering drawings, construction documentation, RFIs, and submittals.
- Construction management, field engineering, and project execution experience.
- Strong knowledge of project scheduling, risk management, and quality inspections.
- Biologics or ADC manufacturing experience.
- Strong stakeholder and change management skills.
- Pharmaceutical Capital Projects
- GMP/cGMP Compliance
- Cleanroom Construction
- Qualification & Validation
- Construction Management
- Stakeholder Management
- Problem Solving & Leadership
- Onsite, Monday–Friday.
- Experience supporting pharmaceutical manufacturing facility expansion projects is highly preferred.
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