Walker Cole International · 7 hours ago
Process Engineering Specialist
California, United States
Full-time
Onsite
Mid, Senior Level
$160K/yr - $185K/yr
3+ years expWalker Cole International is currently supporting a pharmaceutical manufacturing client in California with the search for a Process Engineering Specialist. This role will play a key part in supporting GMP manufacturing operations, focusing on process engineering, validation activities, and packaging operations across clinical and commercial programs.
Staffing & Recruiting
Responsibilities
Provide process engineering support across small-molecule manufacturing operations, including formulation, scale-up, and tech transfer
Lead and support process validation activities (IQ/OQ/PQ), continued process verification, and lifecycle management
Support packaging operations, including line setup, process optimisation, equipment qualification, and change management
Collaborate closely with Manufacturing, Quality, MSAT, and Validation teams to ensure robust and compliant processes
Author, review, and execute technical documentation including protocols, reports, SOPs, and risk assessments
Drive continuous improvement initiatives focused on yield, efficiency, robustness, and compliance
Ensure activities are performed in line with cGMP, FDA, and ICH guidelines
Qualification
Required
Bachelor's or Master's degree in Chemical Engineering, Process Engineering, Chemistry, or a related discipline
3-10 years of industry experience in a GMP environment
Strong background in process engineering and process validation within a GMP environment
Hands-on experience supporting packaging operations, equipment qualification, and packaging process optimisation
Experience with technology transfer, scale-up, and commercial manufacturing support
Strong documentation, problem-solving, and communication skills
Company
Walker Cole International
Walker Cole International offers Executive Search, Talent and Interim solutions to the Pharmaceutical, Life Science and Digital Health industries.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase