Project Engineer, Quality Engineering

Project Engineer

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across three locations. Argonaut partners with innovative biopharmaceutical companies to support the development and commercial manufacturing of drug products. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final packaging. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

The pay range for this position is $105K - $118K annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.

The Project Engineer leads the planning, execution, and delivery of engineering projects supporting Argonaut's drug product manufacturing operations. Projects may span facilities, utilities, equipment, and manufacturing systems, with a focus on safety, GMP compliance, reliability, and production readiness.

This role works independently and cross-functionally with Manufacturing, Quality Assurance, Facilities, IT, and external vendors and contractors to deliver projects from concept through implementation. The Senior Project Engineer will help ensure the site has the facilities, equipment, and infrastructure needed to support safe, compliant, and reliable operations.

Work Schedule:

This is an on-site, Monday–Friday position, 8 hours per day, excluding lunch. Flexible start time between 7:00 a.m. and 9:00 am; consistent schedule once established. Overtime, weekends, and holidays may be required based on business and project needs.

• Lead capital and facility/equipment projects from concept through turnover, ensuring scope, schedule, and budget adherence.
• Ensure all engineering work meets regulatory, validation, and documentation standards.
• Partner with Manufacturing, QA, Facilities, EHS, and IT to align project execution with operational needs.
• Oversee external partners, negotiate scope, manage deliverables, and ensure safe, compliant execution.
• Author and manage change controls, URS, FAT/SAT protocols, commissioning, qualification, and turnover packages.
• Identify risks early, develop mitigation plans, and escalate appropriately.
• Ensure equipment and systems are ready for production, including training, SOP updates, and maintenance integration.
• Drive reliability, efficiency, and safety improvements across facilities and equipment

• Bachelor's degree in Mechanical, Electrical, Chemical, or related Engineering.
• 4–7 years of engineering experience in biotech, pharmaceutical, medical device, or other regulated manufacturing environments.
• Demonstrated experience leading capital, equipment, or facility projects.
• Strong understanding of GMP, validation, change control, and Commissioning & Qualification (C&Q).
• Working knowledge of equipment lifecycle management and facilities/utilities systems, including HVAC, purified water, and compressed air.
• Strong project management, technical writing, and documentation skills.
• Understanding of construction safety and EHS requirements.

• Experience with drug product manufacturing, aseptic operations, or fill-finish equipment.
• Experience managing project budgets exceeding $250K.
• Experience with CMMS, AutoCAD, Bluebeam, and/or project management software.
• Experience with facilities or utilities engineering.
• Lean or Six Sigma certification.
• Familiarity with PMBOK, Lean, or other project management methodologies.

• Ownership:
  Works independently, drives clarity, and closes loops.
• Communication:
  Provides clear, concise updates to stakeholders and leadership.
• Vendor Management:
  Holds vendors accountable for quality, safety, and timelines.
• Problem Solving:
  Applies structured, data-driven approaches to resolve issues.
• Adaptability:
  Performs effectively in a fast-paced environment and navigates changing priorities.

Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed…