QC Project Engineer

ELIQUENT Life Sciences; Costa Mesa (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

ELIQUENT Life Sciences in Costa Mesa, California, is seeking an engineer to execute and manage capital projects in the life sciences industry. Responsibilities include collaborating with clients, ensuring adherence to project timelines, and supporting project lifecycle activities.

The ideal candidate will have 3-5 years of engineering experience, especially with vendor coordination, and be able to be onsite in Orange County. Experience with Quality Control Instrumentation is preferred.

Qualifications

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

Responsibilities

• Execute engineering and capital projects in life sciences.
• Collaborate with clients to define project goals and specifications.
• Support capital projects throughout their lifecycle.

Skills

Engineering experience

Vendor coordination

Quality Control (QC) Instrumentation

Job description

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.

Requirements

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