Process Engineer (Biotech)

TL;DR

Process Engineer (Biotech/Pharma): Supporting capital projects, facility upgrades, and qualification activities within regulated manufacturing environments with an accent on cGMP compliance and lifecycle documentation. Focus on developing URS, design protocols, and ensuring alignment with global regulatory expectations.

Location: Onsite in Irvine, California

Salary: $100,000 – $130,000 annually

Company

An international employee-owned project delivery firm specializing in the pharma, biotech, and medical technology sectors.

What you will do

• Act as an embedded technical resource within client engineering, validation, or operational teams.
• Support capital projects, facility upgrades, commissioning, and qualification activities.
• Develop and review lifecycle documentation including URS, design documentation, protocols, reports, and SOPs.
• Collaborate with cross-functional teams including Engineering, Manufacturing, Quality, Facilities, and IT.
• Ensure all activities align with cGMP regulations and global regulatory expectations.
• Identify risks, escalate issues proactively, and support schedule and budget objectives.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related discipline.
• Experience within pharmaceutical, biotechnology, or regulated manufacturing environments.
• Knowledge of GMP regulations, validation lifecycle principles, and documentation practices.
• Strong communication and stakeholder management skills.
• Experience supporting capital projects or manufacturing operations.

Culture & Benefits

• Employee-owned company structure fostering commitment and drive.
• Inclusive culture with a strong emphasis on diversity, mutual respect, and belonging.
• Corporate strategy centered on Sustainability and Corporate Responsibility.
• Fair and accessible hiring process with reasonable accommodations for candidates with disabilities.