QC Project Engineer
Listed on 2026-07-02
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Engineering
Quality Engineering, Pharma Engineer
Salary Range: $90,000.00 To $ Annually
Who Are We?ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.
Why explore your future at ELIQUENT?ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.
Responsibilities- Execute engineering and capital projects within the life sciences industry, ensuring adherence to project timelines, budgets, quality standards, and regulatory requirements.
- Collaborate with clients and stakeholders to define project goals, requirements, and technical specifications while ensuring alignment with industry best practices.
- Support capital projects throughout the full project lifecycle, from initiation through implementation and closeout, including:
- Development of project funding requests and capital authorization packages
- Creation of project execution plans, project manuals, and change control strategies
- Tracking project deliverables, equipment lead times, budgets, schedules, and contractor performance
- Coordination of submittal reviews and Requests for Information (RFI) reviews
- Conduct technical assessments and review engineering documentation for completeness and compliance.
- Generate lifecycle documentation, including User Requirements Specifications (URS), Functional Design Specifications (FDS), and Design Specifications (DS).
- Develop, execute, and review commissioning, qualification, and validation documentation, including FATs, SATs, commissioning protocols, and qualification protocols.
- Work with vendors, contractors, and client stakeholders to incorporate new assets into the client's asset management and maintenance systems.
- Participate in project meetings, forecasting activities, budget reviews, schedule updates, and status reporting.
- Coordinate commissioning and qualification activities for facilities, utilities, equipment, and manufacturing systems.
- Support project closeout activities, turnover documentation, and transition to operations.
- At least 3-5 years of engineering experience with vendor coordination
- Ability to be onsite in Orange County
- Experience with QC Instrumentation preferred
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