MSAT Process Engineer

ELIQUENT Life Sciences; Los Angeles (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

ELIQUENT Life Sciences in Los Angeles, CA is seeking a Process Validation Engineer to design, execute, and document validation protocols ensuring processes meet quality standards and regulatory requirements. You will work with manufacturing, QA, and R&D to identify improvements and troubleshoot issues.

The final deliverables include validation reports and documentation for regulatory submissions and internal audits.

Qualifications

• 3-8 years of experience in life sciences manufacturing and process validation.
• Experience with Upstream Processing, Filtration Technologies, and DOE.
• Strong GMP manufacturing support and technical writing.

Responsibilities

• Design, execute, and document validation protocols to confirm process robustness.
• Collaborate with manufacturing, QA, and R&D to identify improvements.
• Prepare comprehensive validation reports for regulatory submissions and audits.
• Ensure processes are optimized for efficiency, compliance, and product safety.

Skills

Protocol and report writing

Validation/qualification documentation

Engineering project execution

SOP authoring

Data analysis

Process documentation

Cross-functional coordination

Education

MSAT / Manufacturing Science

Job description

The Process Validation Engineer plays a critical role in ensuring that manufacturing processes consistently produce products that meet predetermined quality standards and regulatory requirements. This position involves designing, executing, and documenting validation protocols to confirm that processes are robust, reliable, and capable of producing high-quality outputs. The engineer will collaborate closely with cross-functional teams including manufacturing, quality assurance, and research and development to identify process improvements and troubleshoot issues. A key outcome of this role is to provide comprehensive validation reports and technical documentation that support regulatory submissions and internal quality audits. Ultimately, the Process Validation Engineer ensures that manufacturing processes are optimized for efficiency, compliance, and product safety within the manufacturing environment in the United States.

Required:

• 3-8 years of experience
• Life Sciences / Biopharmaceutical ManufacturingMSAT / Manufacturing Science
• Process Validation
• Upstream Processing
• Filtration Technologies (Filter Press, UF/DF, TFF)
• Process Development & Process Characterization
• DOE and Data Analysis
• GMP Manufacturing Support
• Technical Writing (SOPs, Protocols, Reports)
• Cross-Functional Manufacturing Support

Required Skills: Protocol and report writing, validation/qualification documentation, engineering project execution, SOP authoring, data analysis, process documentation, cross-functional coordination