Clark & Enersen · 1 month ago
MSAT Engineer
Los Angeles, CA, US
Full-time, Part-time
Hybrid
Mid Level
$100K/yr - $115K/yrELIQUENT Life Sciences is a leading global consulting firm focused on providing solutions to life science companies. The MSAT Engineer will support the Existing Commercial Product Improvement Project as a Subject Matter Expert, engaging in process validation, technology transfer, and manufacturing science activities.
Consulting
Responsibilities
Lead or support deviations, investigations, and CAPA activities related to drug product manufacturing
Serve as process owner for designated unit operations or systems, including purification, upstream processing, and plasma-derived product fractionation steps
Support and provide SME input for filtration operations—particularly filter press systems—and related unit operations involving buffers, vessels, and UF/DF or TFF skids
Perform data analysis to support process understanding, validation, technology transfer, and DOE (Design of Experiments) studies
Author, review, and manage technical documentation including SOPs, batch records, validation protocols, and technical reports
Conduct non-GMP laboratory development work, including sample testing, data analysis, and method evaluation to support process characterization and optimization prior to GMP execution
Collaborate as a liaison between development labs, manufacturing operations, QA, Regulatory Affairs, Engineering, and other cross-functional teams
Prepare technical slide decks, data summaries, and presentation materials for internal reviews and external regulatory interactions, including meetings with the FDA
Contribute to the preparation and review of regulatory submissions (e.g., Module 3, 3.2.P.3)
Participate in technology transfer activities to ensure smooth transition from development to GMP operations
Qualification
Required
Strong knowledge of process validation principles and the PV lifecycle (PPQ, continued process verification)
Experience supporting or leading technology transfer projects in a GMP environment
Demonstrated proficiency in deviation and investigation writing, CAPA, and change control management
Hands-on experience authoring SOPs, protocols, reports, and other technical documentation
Ability to analyze and interpret manufacturing, analytical, and development data
Ability to work in both development (non-GMP) and GMP environments as processes advance through the lifecycle
Preferred
Experience with purification processes, upstream operations, plasma fractionation, filtration (including filter press systems), buffer preparation, and UF/DF or TFF skids preferred
Familiarity with regulatory expectations for submissions and dossier content
Strong communication, collaboration, and presentation skills, including ability to prepare and present data to regulatory agencies
Experience working in biologics, sterile injectables, or plasma-derived product manufacturing is highly preferred
Benefits
Health, dental, vision, and life insurance
A 401(k) plan with employer match
A generous paid time off policy
Additional perks
Company
Clark & Enersen
Clark & Enersen was founded in 1946 in by Architect Kenneth B. Clark and Landscape Architect Lawrence A.
Founded in 1946
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase