Process Engineer III/Senior

Scientific Search; Washington; On-site; USD 80,000 - 120,000; Full time

Job summary

A global CDMO is seeking a Process Engineer III/Senior for an onsite role in Washington State. Key responsibilities include overseeing pharmaceutical processes, managing technical transfers, and leading projects to improve efficiency and quality. Candidates must have a Bachelor's degree in a relevant field and significant experience in the pharmaceutical or FDA-regulated industry. This role requires strong project management, analytical skills, and a focus on lean manufacturing principles.

Qualifications

• 3-7 years related pharmaceutical or FDA-regulated industry experience.
• Master’s degree counts as 2 years of experience.
• Supervisory or leadership experience required.

Responsibilities

• Oversee pharmaceutical processes and technical transfers.
• Engage in and manage projects.
• Design and optimize manufacturing processes.

Skills

Project Management

Statistical Analysis

Lean Manufacturing Principles

Leadership

Education

Bachelor’s degree in Biology, Chemistry, Physics, or Engineering

Job description

Overview

Process Engineer III/Senior (Weekend day shift, Fri-Sunday). Onsite, Washington State (relocation provided).

Company Profile: A global CDMO that provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. A nationally recognized contract manufacturer of sterile injectable vials and lyophilized products.

What You Will Be Doing

• Provide ownership and focus for pharmaceutical processes and technical transfers
• Engage in and manage projects and multi-disciplinary teams with direct supervision
• Contribute technical direction for complex projects and communicate clearly with all levels of employees
• Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainability
• Oversee and assess existing processes and workflows
• Establish and track process metrics to monitor process stability and identify areas for improvement
• Technical transfer of new products from both internal and external clients
• Own product process from initial quote to product retirement
• Develop CPPs and CQAs to support transfer to Manufacturing
• Author validation study documents to demonstrate process capability
• Develop and execute validation studies for new and improved manufacturing processes
• Troubleshooting, oversight and/or sampling of events within Manufacturing with occasional off-shshift support
• Generate reports summarizing study results and use data to qualify site processes
• Review department data for potential trends that could impact quality of sterile products; implement corrective actions when warranted
• Participate in or perform deviation investigations and evaluate impact
• Implement effective CAPAs
• Optimize gross profit margin and minimize deviation rate
• Provide reviews for regulatory and client audits and respond to audit observations
• Understand cGMPs, European regulatory requirements, relevant USP chapters, and principles related to clean room operations and related sterilization and microbiological control
• Minimal travel

What You Will Bring To The Table

• Process Engineer III: 3-7 years related pharmaceutical or FDA-regulated industry experience; Bachelor’s degree in Biology, Chemistry, Physics, or Engineering required; Master’s degree counts as 2 years of experience
• Project Management required
• Statistical Analysis
• Lean Manufacturing Principles
• Supervisory or leadership experience required

• Senior Process Engineer (in addition to above): 5-10 years related pharmaceutical experience or FDA-regulated industry experience; Supervisory or leadership experience required

Contact

Please reach out to Kiera Kelleher at [e-mail] to learn more about this opportunity.