Project Engineer III

Siegfried•Irvine, CA

1d•$125,000 - $135,000•Onsite

About The Position

The Project Engineer III is responsible for leading and executing capital investment (CAPEX) projects and strategic engineering initiatives that support manufacturing operations, facility expansion, equipment upgrades, process improvements, and new product introductions within a highly regulated pharmaceutical environment. This role provides technical leadership throughout the full project lifecycle, from concept development and design through commissioning, qualification, validation, implementation, and ongoing operational support. As a subject matter expert, Project Engineer III supports new product introductions, equipment lifecycle management, process optimization, and infrastructure expansion projects. This role requires strong technical expertise in pharmaceutical manufacturing systems, commissioning and qualification practices, project management, and engineering problem-solving, with the ability to influence cross-functional teams and deliver sustainable business results. The successful candidate will demonstrate a combination of project leadership, engineering excellence, and hands-on technical capability to enhance manufacturing performance, improve equipment reliability, maintain regulatory compliance, and support the organization's long-term growth objectives.

Requirements

Bachelor's degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, Pharmaceutical Engineering, or a related engineering discipline.
Minimum 4 years of engineering experience within the pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing industries.
Minimum 2 years of direct experience in equipment commissioning, qualification, and validation (CQV).
Proven experience managing CAPEX projects involving manufacturing equipment, cleanroom facilities, utility systems, and process improvements.
Demonstrated experience supporting GMP-regulated manufacturing environments.
Hands-on experience with equipment installation, startup, troubleshooting, and qualification activities.
Experience working in classified cleanroom environments.
Strong understanding of pharmaceutical manufacturing processes and quality systems.

Nice To Haves

Experience interacting with external vendors, contractors, and regulatory auditors preferred.

Responsibilities

Lead and manage CAPEX projects from concept through completion, including facility expansions, utility upgrades, equipment installations, manufacturing process improvements, and infrastructure enhancements.
Develop project charters, business justifications, budgets, schedules, resource plans, and risk mitigation strategies.
Monitor project progress, spending, and milestones to ensure projects are delivered safely, on schedule, and within budget.
Coordinate internal stakeholders, contractors, OEMs, consultants, and suppliers throughout the project lifecycle.
Develop detailed project plans and oversee implementation of equipment, process, and facility upgrades.
Lead and coordinate equipment commissioning, qualification, and validation activities in accordance with GMP and validation lifecycle requirements.
Develop and review User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
Support Computer System Validation (CSV) and Data Integrity initiatives where applicable.
Coordinate and execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities for new equipment and systems.
Ensure qualification documentation is complete, accurate, and audit ready.
Conduct engineering investigations and provide technical leadership in the resolution of deviations, non-conformances, quality events, and CAPAs.
Perform root cause analysis and implement sustainable corrective and preventive actions.
Evaluate process performance, equipment reliability, and operational metrics to identify improvement opportunities.
Develop and implement engineering solutions that improve process robustness, product quality, safety, and manufacturing efficiency.
Analyze equipment and process performance trends to proactively identify and address operational risks.
Develop, review, approve, and maintain engineering documentation including SOPs, maintenance procedures, calibration procedures, specifications, drawings, P&IDs, equipment files, and technical reports.
Ensure engineering activities comply with GMP, FDA, EU, ISO, and internal quality system requirements.
Maintain accurate project documentation, change control records, validation files, engineering drawings, and asset documentation.
Support internal and external audits and regulatory inspections as a subject matter expert.
Collaborate with Manufacturing, Quality Assurance, Validation, Maintenance, Supply Chain, EHS, and Regulatory Affairs to support business objectives.
Facilitate communication among project teams and functional stakeholders to ensure alignment and successful project execution.
Lead project meetings and present project status, risks, budgets, timelines, and technical recommendations to management.
Mentor and train operators, technicians, and inspectors on equipment operation, troubleshooting, process controls, and inspection techniques.
Provide technical support and engineering expertise to maintenance, operations, and project management teams.
Participate in strategic planning activities related to facility capacity, manufacturing expansion, and technology implementation.