Sr Process Engineer (Biotech)

Our client, a leading Biotech company, is looking for a skilled Senior Process Engineer to join their team in Rancho Dominguez, CA.

Location:

Rancho Dominguez, CA (100% Onsite)

Job Type:

1 year contract (possibility of extension) Pay rate : $90 - $110/hr.

DOE Department:

Engineering / Manufacturing Operations Position Summary We are seeking a highly motivated and experienced Senior Process Engineer to support the stand-up of a contract manufacturing line for filter module production internationally. This individual will lead process development activities and manage the full technology transfer scope for end-to-end manufacturing processes between global sites. 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 Responsibilities Lead multi-product engineering projects involving: Technology transfer Process development Process validation Manufacturing line implementation and improvements Drive end-to-end tech transfer activities between domestic and international manufacturing sites, including contract manufacturing partners internationally.. Partner closely with global engineering and operations teams to support manufacturing equipment and process transfers. Support and oversee process development activities at contract manufacturing sites. Define, execute, and document: Process qualifications Equipment qualifications Material validations Author and maintain engineering documentation including: User Requirement Specifications (URS) Drawings and technical specifications Validation protocols and reports Change controls Process documentation Lead harmonization and standardization of manufacturing process documentation across sites. Serve as a Subject Matter Expert (SME) for filtration and bioprocess manufacturing systems. Identify and implement process improvements to enhance quality, scalability, efficiency, and compliance. Utilize statistical analysis tools to support validation, troubleshooting, and process optimization efforts. Mentor junior engineers and contribute to engineering best practices and training initiatives. Communicate project scope, timelines, risks, and progress updates to senior leadership and cross-functional stakeholders. Qualifications Bachelor's degree in Engineering or related technical discipline required. 7-10+ years of engineering experience, preferably within medical device or regulated manufacturing industries. Preference for candidates with senior-level experience on the higher end of the range. Process development and process validation International technology transfer projects Manufacturing equipment qualification Filtration systems, including: Hollow Fiber systems Flat Sheet Membranes

GMP, ISO

9001, and/or

ISO 13485

manufacturing environments Data analysis and process optimization Cross-functional project leadership in matrixed organizations INDBH #LI-AH1