Job Description

Senior Process Engineer (Contract - 12 Months)

Location: Compton, CA

Pay Rate: $60 - 100/hr. W2

Must Have

• Manufacturing Transfers
• Process Development (PD)
• Tangential Flow Filtration (TFF)

We are looking for someone with previous experience with process development, filtration systems & tech transfers between international sites. Med Device background would be ideal. The JD states 7-10 years of experience, we would prefer someone on the higher end. There will be multiple milestones within this project and success will be measure on quality of work and ability to meet deadlines.

This is a fully onsite role, starting at 1 year with the potential to extend."

The ideal candidate has a strong background in medical device manufacturing, process engineering, and process validation, preferably within GMP, ISO 9001, or ISO 13485 environments. Success in this role requires technical proficiency, a collaborative mindset, and the ability to drive projects with minimal oversight.

Responsibilities:

• Lead projects in tech transfer, process development, process validation, and line improvements.
• Partner with global engineering teams to support the transfer of manufacturing equipment and processes to contract manufacturing sites
• Support process development activities at contract manufacturing sites.
• Define and execute process, material, and equipment qualifications
• Author and maintain engineering documentation including user requirement specification (URS), drawings, test protocols, change controls, and technical reports.
• Spearhead the review and harmonization of existing manufacturing process documentation
• Act as a Subject Matter Expert for filtration and other bioprocessing manufacturing systems.
• Identify and implement process improvements, ensuring compliance with industry standards and regulations.
• Mentor junior team members and support standardization and training of best practices.
• Apply statistical tools to support validation and process optimization efforts.
• Drive innovation in filtration systems and related support infrastructure to enhance performance and scalability.

Education and/or Work Experience:

· Bachelor’s degree in Engineering required.

· 7–10 years of experience in medical devices or similar fields.

· Hands-on experience with:

· Process validation and equipment qualification

· Tech transfer between international sites

· Data analysis and automation

· Filtration systems (Hollow Fiber, Flat Sheet Membranes)

· Strong knowledge of ISO 9001, ISO 13485, or GMP manufacturing standards.

· Proficient in SolidWorks/CAD, MS Office, and electronic file management systems.

· Familiarity with single-use systems, sterilization techniques, and lean manufacturing principles preferred.

· Demonstrated ability to lead cross-functional teams and manage projects in a matrixed organization.

· High level of personal integrity, adaptability, and leadership by example.

Other requirements:

· Capable of independently defining and executing projects.

· Provides technical direction and feedback to teams across disciplines.

· Balances day-to-day plant support (20%) with project execution (80%).

· Communicates clearly with senior leadership on project scope, risks, and progress.

· Delegates tasks effectively and contributes to team development.

Physical Requirements:

· Regular work in cleanroom and laboratory environments.

· Exposure to chemicals, mechanical systems, and occasional electrical hazards.

· May be required to lift up to 50 lbs and operate in areas with noise and vibration.