Pharma Project Engineer III - CAPEX & CQV Leader

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

Benefits offered by this job

Medical, Dental, Vision

401K plan

HSA options

Life Insurance

Disability insurance

Pet Insurance

Flexible Spending Account

Job summary

Siegfried is seeking a Project Engineer III to lead capital projects in a GMP-regulated pharmaceutical environment, driving expansion, innovation, and operational excellence. This is a hands-on role where you will partner with manufacturing and quality teams to ensure projects deliver reliable systems and compliant processes.

You will manage projects from concept through commissioning, qualification, validation and startup, coordinating with Facilities, Validation, and vendors to meet timelines

Qualifications

• Bachelor’s degree in Engineering.
• 4+ years in regulated pharma/biotech manufacturing.
• 2+ years CQV experience.
• CAPEX project management experience.
• GMP manufacturing and validation experience.
• Cleanroom experience.

Responsibilities

• Lead CAPEX projects including facility expansions, utility upgrades, equipment installations, and process improvements.
• Manage projects from concept through commissioning, qualification, validation, and operational handoff.
• Develop project plans, budgets, schedules, and risk mitigation strategies.
• Coordinate contractors, vendors, OEMs, and cross-functional stakeholders.
• Lead FAT, SAT, and CQV activities with URS, DQ, IQ, OQ, and PQ documentation.
• Support new product introductions and process optimization; drive CAPA and continuous improvement.
• Ensure GMP compliance and alignment with FDA/quality system requirements.

Skills

CAPEX mgmt

CQV experience

GMP knowledge

Project planning

Vendor coordination

Education

Engineering degree

Tools

URS

DQ

IQ

OQ

PQ

Job description

Siegfried is seeking a Project Engineer III to lead capital projects in a GMP-regulated pharmaceutical environment, driving expansion, innovation, and operational excellence. This is a hands-on role where you will partner with manufacturing and quality teams to ensure projects deliver reliable systems and compliant processes.

You will manage projects from concept through commissioning, qualification, validation and startup, coordinating with Facilities, Validation, and vendors to meet timelines