Job TitleELIQUENT 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.ActivitiesExecute 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 packagesCreation of project execution plans, project manuals, and change control strategiesTracking project deliverables, equipment lead times, budgets, schedules, and contractor performanceCoordination of submittal reviews and Requests for Information (RFI) reviewsConduct 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.RequiredAt least 3-5 years of engineering experience with vendor coordinationAbility to be onsite in Orange CountyExperience with QC Instrumentation preferred