Senior CAPEX Project Engineer – Pharma Manufacturing

Siegfried; Irvine (CA); On-site; USD 125,000 - 135,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K

Life Insurance

Pet Insurance

Flexible Spending & HSA

Job summary

Siegfried is seeking a Project Engineer III to lead and execute CAPEX projects in a highly regulated pharmaceutical environment. You will oversee concept through commissioning, qualification, validation, and ongoing support, driving cross-functional collaboration and engineering excellence.

Ideal candidates bring 4+ years in pharma engineering, CQV experience, and a strong track record of delivering compliant, cost-effective capital projects that enhance manufacturing performance and reliability.

Qualifications

• Bachelor’s degree in a related engineering field.
• 4+ years engineering experience within pharma or regulated manufacturing.
• 2+ years direct experience in CQV (equipment commissioning, qualification and validation).
• Experience managing CAPEX projects involving manufacturing equipment, cleanrooms, utilities, and process improvements.
• Hands-on experience with equipment installation, startup, troubleshooting, and qualification activities.

Responsibilities

• Lead and manage CAPEX projects from concept through completion, including facility expansions, utility upgrades, equipment installations, and process improvements.
• Develop project charters, budgets, schedules, risk mitigation strategies, and stakeholder plans.
• Coordinate internal stakeholders, contractors, and suppliers across the project lifecycle.
• Lead equipment commissioning, qualification, and validation activities (GMP/validation lifecycle) and ensure audit-ready documentation.
• Provide technical leadership to improve manufacturing performance and equipment reliability.

Skills

Project management

CAPEX leadership

GMP knowledge

Cross-functional leadership

Regulatory compliance

Education

Bachelor's degree in Mechanical Engineering

Job description

Siegfried is seeking a Project Engineer III to lead and execute CAPEX projects in a highly regulated pharmaceutical environment. You will oversee concept through commissioning, qualification, validation, and ongoing support, driving cross-functional collaboration and engineering excellence.

Ideal candidates bring 4+ years in pharma engineering, CQV experience, and a strong track record of delivering compliant, cost-effective capital projects that enhance manufacturing performance and reliability.