QC Project Engineer

Job Title

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.

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.

Activities:

• 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.

Required:

• At least 3-5 years of engineering experience with vendor coordination
• Ability to be onsite in Orange County
• Experience with QC Instrumentation preferred