JOBSEARCHER

Sr Process Engineer

AstrixCompton, CAApril 25th, 2026
Pay Rate Low: 100 | Pay Rate High: 105Senior Process Engineer (Contract)Location: Rancho Dominguez, CA (100% Onsite)Duration: 12+ month contract with potential extensionWe are seeking an experienced Senior Process Engineer to support a high-impact manufacturing expansion initiative involving the transfer and scale-up of a complex filtration manufacturing process to an international contract manufacturing site. This individual will play a critical role in leading process development activities, driving technology transfer strategy, and ensuring successful implementation across global manufacturing teams.This position requires a strong technical background in process engineering, process validation, and manufacturing support within regulated environments.The ideal candidate will bring hands-on experience with international tech transfers, filtration systems, and cross-functional project leadership within medical device, bioprocessing, or related manufacturing industries.Key ResponsibilitiesLead end-to-end technology transfer and process development activities for manufacturing operations at international contract manufacturing sitesPartner with global engineering and manufacturing teams to support transfer of manufacturing equipment, processes, and documentationDrive process validation, equipment qualification, and manufacturing readiness initiativesDevelop and execute process, material, and equipment qualification protocolsAuthor and maintain technical documentation including protocols, change controls, engineering reports, user requirement specifications (URS), and process documentationReview, update, and harmonize manufacturing process documentation to ensure consistency across sitesServe as a Subject Matter Expert (SME) for filtration and bioprocess manufacturing systemsIdentify and implement process improvements to support efficiency, scalability, and compliance objectivesUtilize statistical analysis tools to support validation activities and process optimization effortsSupport troubleshooting, root cause investigations, and continuous improvement initiativesProvide technical guidance and mentorship to cross-functional teams and junior engineersCommunicate project updates, risks, timelines, and milestones to senior leadership and key stakeholdersQualificationsBachelor’s degree in Engineering or related technical discipline required7+ years of experience in process engineering, manufacturing engineering, or process development within medical device, bioprocessing, or highly regulated manufacturing environmentsStrong experience with:International technology transfers and manufacturing scale-up initiativesProcess validation and equipment qualificationFiltration systems, including hollow fiber and flat sheet membrane technologiesGMP, ISO 9001, and/or ISO 13485 regulated manufacturing environmentsData analysis and process optimization methodologiesExperience supporting contract manufacturing organizations (CMOs/CDMOs) strongly preferredProficiency with CAD/SolidWorks, Microsoft Office, and electronic document management systemsFamiliarity with lean manufacturing principles, sterilization processes, and single-use systems preferredDemonstrated ability to lead projects independently and operate effectively within matrixed organizationsAdditional InformationThis role is heavily project-focused, with approximately 80% dedicated to project execution and 20% supporting day-to-day manufacturing operationsPosition requires strong collaboration with international teams across multiple time zonesMust be comfortable working onsite in manufacturing, laboratory, and cleanroom environmentsAbility to lift up to 50 lbs and work around mechanical systems, chemicals, and industrial equipment as neededINDBH